How Can Clinical Trials Be Accessed?

How Can Clinical Trials Be Accessed?  from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack and patient advocate Sujata Dutta explain the benefits of participating in a clinical trial. They review important questions to ask your doctor and share advice for finding a trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

What Is a Clinical Trial and What Are the Phases? 

Are Clinical Trials Safe?

A Patient Shares Her Clinical Trial Experience


Transcript:

Katherine Banwell:    

Sujata, there’s clearly a lot of hesitation and misconceptions out there. What would you say to someone who’s considering a trial but is hesitant?

Sujata Dutta:  

I would say speak to your provider, speak to your doctor, and get all these myths kind of busted to say, “it’s going to be expensive” or whatever those questions are. And then, through that process also try and understand what is it that the study is trying to achieve? How is that going to be beneficial to you? So, in my instance, it wasn’t the last line of defense, it was just one of the processes or combos that would help me. And so, that was important for me to understand and then a little bit of education as well. So, I was asking, I have questions on my phone every time I meet my provider, and I did the same thing. So, I think that one of the good practices is keep your note of your questions and have those questions ready. And no question is silly, all questions are important. So, ask as many questions as you can and use that opportunity to educate yourself about it.

And maybe you realize, “No. I don’t think it’s working for me” or “I don’t think this trial is good for me.” But it’s good, important, to have that conversation with your provider, that’s what I would recommend highly.

Katherine Banwell:    

Excellent. Thank you, Dr. Pollack, if someone is interested in participating, how can they find out about what trials are even available for them?

Dr. Seth Pollack:       

Yeah. I mean, the best thing to do is to start just by asking your doctor if they know about any clinical trials. And a lot of the times the clinical trials are run at the big medical centers that may be closer to you, so you could ask your doctor if there’s any clinical trials at the big medical center even. Or I always think it’s good to get a second opinion, you could go get a second opinion at the big medical center that’s close to you and ask them what clinical trials are at your center.

And sometimes they’ll be conscious about some of the clinical trials that may be even run around the country. And you can ask about that as well.

Katherine Banwell:    

Would specialists have more information about clinical trials than say a general practitioner?

Dr. Seth Pollack:       

So, I specialize in rare cancers, so a lot of the times the general practitioners they’ve got my cell phone number, and they text me, and they say, “Hey, do you have a clinical trial going on right now?” And that happens all the time, but yeah, the specialists will usually because frankly there’s so much to know. And the general practitioners really have a lot to keep track of with all the different types of diseases that are out there. Whereas at the big centers, the specialists, part of their job is really to keep their tabs on what’s going on with the clinical trials.

So, they’re good people to ask, either your local doctor could reach out to them, or you could go get a second opinion and ask.

Sujata Dutta:  

There’s also a lot of information, Katherine, on sites such as LLS, or PEN, or American Cancer Society that they also publish a lot of information. Of course, I would recommend once you have that information then vet it by your specialist, or whatever. But if you’re interested in knowing more about clinical trials in general and some that would work for you, then those are also some places to get information from.

Katherine Banwell:    

That’s great information. Thank you, I was going to ask you about that Sujata. Well, before we end the program, Dr. Pollack, I’d like to get your final thoughts. What message do you want to leave the audience with related to clinical trial participation?

Dr. Seth Pollack:       

Yeah. I think clinical trials it can be a very rewarding thing for a lot of patients to do, I think patients really like learning about the new treatments. And I think a lot of patients really like being a part of pushing the therapies forward in addition to feeling like sometimes they’re getting a little bit of an extra layer of scrutiny, because there’s a whole extra team of research coordinators that are going through everything.

And getting access to something that isn’t available yet to the general population. So, I think there’s a whole host of advantages of going on clinical trials, but you need to figure out whether or not a clinical trial is right for you.

Katherine Banwell:    

Yeah. Sujata, what would you like to add?

Sujata Dutta:  

Absolutely, I second everything that Dr. Pollack is saying. And in my personal experience I wouldn’t say everything is hunky-dory, everything is fine. I’m going through treatment, I have chemo every four weeks, I started with chemo every week. That’s when the logistics pace was really difficult because going to Mayo every week was not easy. But anyways, as the trial progress itself every four weeks, but as I said the benefits are huge because I have labs every four weeks. I meet my provider every four weeks.

So, we go through the labs and anything amiss, I’ve had some changes to my dosage because I’ve had some changes in the labs. And so, there’s a lot of scrutiny which I like, but the flip side, for maybe some maybe like, “I have to have chemo every four weeks. Do I want to do that or not?” Or whatever. In my case, I knew it, and I signed up for it, and I’m committed to doing that for two years. And so, I’m fine with that. So, I would say all in all, I’d see more benefits of being in a clinical trial. One, you’re motivated to give back to the community. Two, you are being monitored and so your health is important to your provider just as it is to you. And so, I highly recommend being part of a trial if it works for you and if you’re eligible for one.

Are Clinical Trials Safe?

Are Clinical Trials Safe?  from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack explains the safety protocols in place for clinical trials, including how data is reported and protected. Patient advocate Sujata Dutta goes on to share her experience in a clinical trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

A Patient Shares Her Clinical Trial Experience

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?


Transcript:

Katherine Banwell:

Some patients feel that clinical trials aren’t safe, is that the case, Dr. Pollack?  

Dr. Seth Pollack:

No. I mean, we go through, as I was saying before, these clinical trials are extensively vetted. So, the safety is, of course, one of the things that we look most carefully about. But as I was saying before, like with any treatment’s cancer treatments have toxicity, that’s a common problem. So, and when you’re dealing with something brand new sometimes there is a little bit more risk. So, when you’re talking about these very early-stage Phase I trials you probably want to talk to your doctor about what sorts of toxicities you can expect and where they are in the Phase I trial. Are you the first ever to receive this new drug? And if you are nobody’s making you go in the clinical trial, so it can only help to get more information. Right? So, you should ask your team about it, you should find out. 

Most of the time there’s going to be a lot of patients that have been treated already, I mean, they can’t give you definitive data about how things are going but they can maybe say, “Hey. I’ve already treated a few patients on it, and they seem to be doing great.” 

Katherine Banwell:

So, you need to weigh the pros and cons of the trial. 

Dr. Seth Pollack:

You do need to weigh the pros and cons. Now, when you’re talking about these Phase IIs and Phase IIIs, I mean, these are drugs now that have really been vetted for their safety and we have a lot of data about it. And even the Phase Is, it’s not like these things are coming out of nowhere, they’ve been scrutinized, we really expect that they’re going to be safe but we’re doing the trial to prove it. So, it’s a good thing to ask about. 

Katherine Banwell:

Yeah, yeah. 

Sujata Dutta:

Yeah. I would also add that it’s so closely monitored that safety is a top priority, it’s front and center. So, the advantage, I think, with being on a trial is the close monitoring of the patient exactly for this reason. 

If something is amiss it’s going to be picked up as quickly as possible and you’re any issues are going to be addressed as soon as. So, I think, safety does get addressed pretty quickly.  

Katherine Banwell:

Good. 

Can data from trials even be trusted? Dr. Pollack, is that the case? 

Dr. Seth Pollack:

Well, of course, I mean, it can be trusted. Because the thing with the clinical trial data is that you really see the data and there’s all kinds of scrutiny making sure that the data is reported accurately. Now, there’s a whole other conversation we could have as to whether we could interpret the data differently. And sometimes that is an issue that comes up, but the data is reported very accurately. 

So, and there are statistics that are very well understood, and the bar is actually pretty high to say one arm of the trial was better than the other arm of the trial. So, if patients have better survival on one arm, if we say that, usually it means they did considerably better. Enough better that it wasn’t a random chance that one extra patient did better on the treatment arm. No. There were enough patients that did better that the statisticians can go through it with a fine-toothed comb. And they can be absolutely sure up to exactly how many percent sure they can tell you, 0.05 percent or less chance of error that this was a real difference between the study arm and the standard of care arm. 

Sujata Dutta:

I think you mentioned too that one is trust, and one is data. So, Dr. Pollack mentioned a lot about the data, I think the trust is also a very important thing. I like to go with positive intent because I do not have a reason to believe my doctor has some ulterior motive to suggest a clinical trial. And so, I trust them wholeheartedly. The first hurdle is you have to trust the system or what is being proposed to you because, as Dr. Pollack said, it’s gone through a lot of vetting. A recommendation to be part of a trial itself is vetted by your doctor when they make the recommendation. So, have faith, trust, that they are making a good recommendation. And then, of course, the data, I don’t know much about that, but as I said, I trust it. So, I would trust the data too. 

Katherine Banwell:

Of course. Of course. Some patients feel like they’re going to lose their privacy. Sujata, did you feel that at all? 

Sujata Dutta:

No. Not at all. 

I mean, with everything else that is also taken care of, my information, or whatever, is not made available to anybody. And so, obviously there’s a lot of people will get those, and I had a huge pile of paperwork to go through, but I think that’s a good thing. For my peace of mind that I knew that my information was not going to be shared outside of the study, the trial, etc., and things. So, no, I don’t think that’s a problem. 

Katherine Banwell:

Beyond these misconceptions is there anything else you hear? Dr. Pollack?  

Dr. Seth Pollack:

No. I mean, look, in our crazy modern world there’s concerns everywhere, but the clinical trial is very, very careful. Whenever possible we use the medical chart.  

And then, we have a very stringently protected database that’s storing people’s information, but it’s deidentified. So, I mean, we have a separate key to figure out who the patients are and then we try to limit the use of the patient’s name or any identifying information about them beyond that. So, and your information is not shared. For example, if there’s a drug company involved in the trial, your information is not shared with the drug company, you have a new identifier that is unique and not traceable back to you that is provided to whoever, if there’s outside groups working on the trial with you. So, your information is very carefully protected, and everyone is very conscious about issues regarding privacy.  

Katherine Banwell:

That’s great to know.  

Are Clinical Trials a Logistical Nightmare?

Are Clinical Trials a Logistical Nightmare?  from Patient Empowerment Network on Vimeo.

PEN board member and myeloma survivor Sujata Dutta shares how her family managed the logistics of her clinical trial participation.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?


Transcript:

Katherine Banwell:    

The logistics will be a nightmare and I don’t live close to a research hospital. Sujata, did you have that issue?

Sujata Dutta:  

Yeah. That’s a very interesting one, and actually I’ll share my experience. I did have this concern about logistics, because I got my transplant at Mayo Rochester, which is a two-hour drive from where I live. And so, when I got to know about it literally me and my husband were like, “Oh, my gosh. What are we going to do?” It’s not just me, my husband is my caregiver, he has to take the day off to drive me to Mayo, wait through my treatment, and drive me back. Then we have boys who were distance learning at the time, and so what do we do with them? Do we drop off a friends or take a favor from a friend? And so on and so forth.

So, the logistics was an issue and we literally said, “Thanks but no thanks” and we walked out of the room. And we came downstairs, and my husband was like, “What the heck?” My team understands everything, and I fortunately work for a very good employer, and they understand everything, people first. And so, he was like, “I can figure this out. Let’s do it if this is what’s going to help you, then let’s just figure this out.” And at that time, it was so good, and I have total respect for Dr. Pollack.

You and everybody in this medical community. My doctor who leads the trial at Mayo, she actually said, “Why don’t you check with your local cancer center? Maybe they are also approved by FDA, and they may be able to administer this treatment to you.” Unfortunately, at that time they weren’t but we were like, “We’re going to go ahead with the trial. It doesn’t matter.” My husband was like, “I’ll take the day off, you don’t worry about it.” And then, four months later my institute did get approved by FDA, and so I was able to transfer from Mayo to my local cancer center, Abramson Cancer Center, which is 20 minutes from home. And so, there are options, I know that it can be an issue and it can be overwhelming at the time which was the case with me. But I was able to overcome that, so maybe there are options available that the patients can consider.

Is It Expensive to Participate in a Clinical Trial?

Is It Expensive to Participate in a Clinical Trial?  from Patient Empowerment Network on Vimeo.

Is there a financial cost to participating in a clinical trial? Dr. Seth Pollack explains how clinical trials participation is billed and potential financial impacts.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Is this fact or fiction; it will be expensive? Dr. Pollack?

Dr. Seth Pollack:       

That’s fiction because the way the clinical trials work is we go through everything very carefully to figure out what things are standard and what things are unique to the clinical trials. So, if you are getting chemotherapy, you’re going to need blood work, you’re going to need the chemotherapy drugs, you’re going to need some sort of imaging, CT scan, or whatever your doctor would do.

And all those sorts of things are considered standard, so your insurance company is built for those. Then there’s a bunch of things that are considered research. For example, there’s special research bloodwork, maybe there’s an investigational agent that’s being added to standard chemotherapy. Those things are billed to the study, so you don’t actually have to pay anything extra, it’s just like you’re getting the normal treatment as far as you’re concerned. I mean, that’s the way it always is, and I haven’t had any of my patients ever get into real problems in terms of the finances of these things. It always works very straight forward like standard therapy.

Is a Clinical Trial a Last-Resort Option?

Is a Clinical Trial a Last-Resort Option?  from Patient Empowerment Network on Vimeo.

Are clinical trials only meant as a last-resort option? Dr. Seth Pollack debunks this common clinical trial misconception and explains why he feels patients should participate when the opportunity arises.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Right. And another concern that people have is; clinical trials are my last resort treatment option. What do you say to that Dr. Pollack?

Dr. Seth Pollack:       

Yeah, no. That’s a common misconception. So, we like to have clinical trials for every phase of the patient’s cancer journey because we’re trying to make every single part of the cancer journey better. So, I think a lot of people think that, okay, when they hit their last resort that’s kind of the time to try something new. Even in the very earliest parts of the cancer journey, even in the diagnosis phase sometimes we’ll have clinical trials where we’ve tried different images, modalities, or look at things in a different way in terms of the biopsies.

But then, in terms of the cured-of treatments, when somebody is in the cured-of setting we don’t usually try something very brand new. But a lot of the times we’ll try something that is very affective for patients at the end, and we want to try and make the cured-of strategy even better. So, a lot of the times for those patients we’ll have new therapies that are very safe and established that we’re trying to incorporate earlier into patients’ treatments because we know they work really well, right? And then, even in patients who have incurable cancer a lot of times it’s better to try a clinical trial earlier on just because sometimes the clinical trials have the most exciting new therapies that are bringing people a lot of hope.

And a lot of the times you want to try that when you’re really fit and when you’re in good shape. So, that’s why I think that you really want to think about doing a clinical trial when the opportunity arises.

Katherine Banwell:    

Yeah. Beause it could be beneficial to you and it’s certainly going to be beneficial to other people.

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?  from Patient Empowerment Network on Vimeo.

Does participating in a clinical trial make you a “guinea pig” for new treatments? Clinical researcher, Dr. Seth Pollack, provides a clear explanation of clinical trial safety protocols.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Well, I’d like to address a list of common concerns about clinical trials that we’ve heard from various audience members prior to this program.

And this is probably the most common; I will be a guinea pig. Dr. Pollack, how do you respond to that?

Dr. Seth Pollack:       

Yeah. I know that is a common concern. I mean, I think the thing that people have to understand about clinical trials is there is just so much oversight that happens for these clinical trials. Every document, every procedure, is scrutinized by multiple committees. There’s a scientific review committee, there’s a review board, IRB, that reviews these. Many of these trials are reviewed by the FDA and they’re reviewed by your doctor and your doctor’s colleagues that are also participating in the trial. So, every detail is discussed at length.

In fact, a lot of the times there’s a lot more structure to being on the clinical trial than just routine clinical care because they’ve thought so thoroughly about when everything needs to be done and what the right timing of is for the various procedures.

A Patient Shares Her Clinical Trial Experience

A Patient Shares Her Clinical Trial Experience  from Patient Empowerment Network on Vimeo.

Sujata Dutta, an empowered patient advocate, explains why she felt participating in a clinical trial was the right decision to treat her myeloma.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Sujata, I understand that you went through a series of treatments for your multiple myeloma, which is a type of blood cancer, including a stem cell transplant.

At what point did you and your doctor consider a clinical trial might be best for you?

Sujata Dutta:  

Yes, you’re right. I was diagnosed with multiple myeloma in December, and so the line of treatment or the standard protocol is that you go through what is called an induction therapy. Which is like a few cycles of chemotherapy which get you ready for a transplant. And the transplant, the hope is that it kind of washes away, or cleans off all the cancer cells for you, or at least brings the cancer to a very, very minimal level. And I did go through six rounds of chemo which got me ready for the transplant, and I went through the transplant in June of 2020. However, I’m amongst the very few, small percentage of people that just did not respond with the transplant. So, I was at the same point as where I started. So, it was a little bit disappointing, but my doctors were there to help me understand the situation. It was a hard pill to swallow.

But anyways, there were options. And that’s what I feel very hopeful about with multiple myeloma is that there are so many options available today through treat, or to at least bring the disease under control to a very large extent. And I expressed a desire to be in a trial very earlier on, so my doctor did know that I would lend a year or two listening to what the trials were. And it just so happened that there was a trial that was very apt in my situation, somebody who had gone through a transplant. They have some criteria, and I was able to meet that criteria. And so, for me, it seemed to be the right decision to make. And so, that’s how I agreed to be part of the trial.

Katherine Banwell:    

Can you go into some detail about why you thought a clinical trial was a best thing for you?

Sujata Dutta:  

Yeah. So, initially before knowing much about the strain that I’m a part of, I just had the desire to be part of a trial because I was always in awe of patients who had been in trials before me.

And because of whom I was benefiting. But whatever regiments, medications, combos, whatever was happening. And so, from that perspective I always wanted to give back in some way. Unfortunately, we are having more people being diagnosed with cancers, with multiple myeloma, and so I was very motivated to do something for the community that I was now part of. And so, I had my transplant at Mayo, and I knew that they had a whole bunch of trials and had access to different types of trials. So, that was my first motivation and it just so happened that, as I said, my experience with transplant didn’t go the desired way. And so, when I heard that there was a possibility that I could be part of a trial, I kind of leaned into actually agreeing to be part of that.

Katherine Banwell:    

Yeah. It sounds like that was the next step for you.

Sujata Dutta:  

Yup.

What Is a Clinical Trial and What Are the Phases?

What Is a Clinical Trial and What Are the Phases?  from Patient Empowerment Network on Vimeo.

How do clinical trials work? Dr. Seth Pollack, a clinical researcher, defines clinical trials and explains what occurs in each of the phases.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

A Patient Shares Her Clinical Trial Experience

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Let’s start with a basic question, Dr. Pollack. What is a clinical trial?

Dr. Seth Pollack:       

Yeah. It’s a basic question, but actually, sometimes, it can be harder to answer than you might think.

I think everybody has an idea in their mind about what a clinical trial is, you’re going to test a new approach. But actually, there’s a whole variety of different things that can be a clinical trial, right? A clinical trial a lot of the times is testing a new drug, could be testing something for the very first time, could be testing something in combination with other drugs for the very first time. It could be testing a standard approach but doing it in a new way. It could even be giving less treatments than we usually do. For example, if there’s a very intense, harsh, standard of care treatment we might even have a clinical trial where we try a little bit less and see that patients do just as well. So, all of those things are clinical trials, but really the clinical trial in its heart is a very organized and careful approach to testing a new treatment strategy for patients.

Katherine Banwell:    

Okay. What are the phases of a clinical trial?

Dr. Seth Pollack:       

Yup. So, the Phase I clinical trial is usually when we’re testing something for the first time in however we’re doing it. So, it could be the first time we’re testing a new drug, or the first time we’re testing a drug in combination with other drugs. And the real thing about a Phase I trial is that the main goal of the trial is to look at the safety and tolerability of the regiment. That doesn’t mean that we’re not really trying to figure out if the regiment works, I mean, that’s also one of the most important things. But the most important thing for a Phase I trial is making sure that it’s safe and tolerable. A Phase II trial is where we, sort of, shift and we’re still making sure, and double checking, that the drug is, but now our main focus becomes on the efficacy of the strategy.

So, now we’re trying to really figure out if this is a strategy that seems affective enough to go to a Phase III. And a Phase III is a big multi-center trial. Frequently those will be placebo controlled where a lot of the times there’ll be randomized trial where we really try to absolutely prove, beyond a shadow of a doubt, that, that strategy is affective. And those are most of the types of trials that patients will encounter.

Katherine Banwell:    

Okay. Thank you for providing clarity around the phases.

Could a Clinical Trial Be Your Best Cancer Treatment Option?

Could a Clinical Trial Be Your Best Cancer Treatment Option? from Patient Empowerment Network on Vimeo.

Is a clinical trial right for you? Cancer expert and researcher, Dr. Seth Pollack is joined by PEN board member and empowered patient, Sujata Dutta, to discuss key information about clinical trials. The guests review clinical trial terminology, debunk common misconceptions about trials, and Sujuta shares her own story of participation in a clinical trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

Download Guide

See More from Clinical Trials 101

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Understanding Clinical Trial Phases

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Transcript:

Katherine Banwell:    

Hello, and welcome. I’m Katherine Banwell, your host for today’s program.

Today we’re going to discuss clinical trials, what they are and how they work, and debunk some misconceptions along the way. Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you. All right. Let’s meet our guests today. Joining me is Dr. Seth Pollack. Dr. Pollack, welcome. Would you please introduce yourself?

Dr. Seth Pollack:

Yeah. Thanks so much. It’s a pleasure to be here, my name is Seth Pollack. I’m a medical oncologist here at Northwestern University Medical Center.

And I specialize in treating patients with cancer, and I have a specific interest in patients with a type of cancer called sarcomas.

Katherine Banwell:    

Excellent. Thank you for taking the time to join us today. And here to share the patient perspective is Sujata Dutta, who is on the board of the Patient Empowerment Network and is currently participating in a clinical trial. Sujata, it’s a pleasure to have you with us.

Sujata Dutta:

Pleasure to be here Katherine. Hello, Dr. Pollack. And hi everyone, my name is Sujata Dutta, and I was diagnosed with a cancer called multiple myeloma in December of 2019. And I’ve been on a clinical trial since September of 2020.

Katherine Banwell:    

Thank you, for that information. And we’re going to go into that further in just a few moments. Let’s start with a basic question, Dr. Pollack. What is a clinical trial?

Dr. Seth Pollack:       

Yeah. It’s a basic question, but actually, sometimes, it can be harder to answer than you might think.

I think everybody has an idea in their mind about what a clinical trial is, you’re going to test a new approach. But actually, there’s a whole variety of different things that can be a clinical trial, right? A clinical trial a lot of the times is testing a new drug, could be testing something for the very first time, could be testing something in combination with other drugs for the very first time. It could be testing a standard approach but doing it in a new way. It could even be giving less treatments than we usually do. For example, if there’s a very intense, harsh, standard of care treatment we might even have a clinical trial where we try a little bit less and see that patients do just as well. So, all of those things are clinical trials, but really the clinical trial in its heart is a very organized and careful approach to testing a new treatment strategy for patients.

Katherine Banwell:    

Okay. What are the phases of a clinical trial?

Dr. Seth Pollack:       

Yup. So, the Phase I clinical trial is usually when we’re testing something for the first time in however we’re doing it. So, it could be the first time we’re testing a new drug, or the first time we’re testing a drug in combination with other drugs. And the real thing about a Phase I trial is that the main goal of the trial is to look at the safety and tolerability of the regiment. That doesn’t mean that we’re not really trying to figure out if the regiment works, I mean, that’s also one of the most important things. But the most important thing for a Phase I trial is making sure that it’s safe and tolerable. A Phase II trial is where we, sort of, shift and we’re still making sure, and double checking, that the drug is, but now our main focus becomes on the efficacy of the strategy.

So, now we’re trying to really figure out if this is a strategy that seems affective enough to go to a Phase III. And a Phase III is a big multi-center trial. Frequently those will be placebo controlled where a lot of the times there’ll be randomized trial where we really try to absolutely prove, beyond a shadow of a doubt, that, that strategy is affective. And those are most of the types of trials that patients will encounter.

Katherine Banwell:    

Okay. Thank you for providing clarity around the phases. Before we move onto safety and benefits of clinical trials, let’s hear from Sujata. Sujata, I understand that you went through a series of treatments for your multiple myeloma, which is a type of blood cancer, including a stem cell transplant.

At what point did you and your doctor consider a clinical trial might be best for you?

Sujata Dutta:  

Yes, you’re right. I was diagnosed with multiple myeloma in December, and so the line of treatment or the standard protocol is that you go through what is called an induction therapy. Which is like a few cycles of chemotherapy which get you ready for a transplant. And the transplant, the hope is that it kind of washes away, or cleans off all the cancer cells for you, or at least brings the cancer to a very, very minimal level. And I did go through six rounds of chemo which got me ready for the transplant, and I went through the transplant in June of 2020. However, I’m amongst the very few, small percentage of people that just did not respond with the transplant. So, I was at the same point as where I started. So, it was a little bit disappointing, but my doctors were there to help me understand the situation. It was a hard pill to swallow.

But anyways, there were options. And that’s what I feel very hopeful about with multiple myeloma is that there are so many options available today through treat, or to at least bring the disease under control to a very large extent. And I expressed a desire to be in a trial very earlier on, so my doctor did know that I would lend a year or two listening to what the trials were. And it just so happened that there was a trial that was very apt in my situation, somebody who had gone through a transplant. They have some criteria, and I was able to meet that criteria. And so, for me, it seemed to be the right decision to make. And so, that’s how I agreed to be part of the trial.

Katherine Banwell:    

Can you go into some detail about why you thought a clinical trial was a best thing for you?

Sujata Dutta:  

Yeah. So, initially before knowing much about the strain that I’m a part of, I just had the desire to be part of a trial because I was always in awe of patients who had been in trials before me.

And because of whom I was benefiting. But whatever regiments, medications, combos, whatever was happening. And so, from that perspective I always wanted to give back in some way. Unfortunately, we are having more people being diagnosed with cancers, with multiple myeloma, and so I was very motivated to do something for the community that I was now part of. And so, I had my transplant at Mayo, and I knew that they had a whole bunch of trials and had access to different types of trials. So, that was my first motivation and it just so happened that, as I said, my experience with transplant didn’t go the desired way. And so, when I heard that there was a possibility that I could be part of a trial, I kind of leaned into actually agreeing to be part of that.

Katherine Banwell:    

Yeah. It sounds like that was the next step for you.

Sujata Dutta:  

Yup.

Katherine Banwell:    

Yeah. Well, I’d like to address a list of common concerns about clinical trials that we’ve heard from various audience members prior to this program.

And this is probably the most common; I will be a guinea pig. Dr. Pollack, how do you respond to that?

Dr. Seth Pollack:       

Yeah. I know that is a common concern. I mean, I think the thing that people have to understand about clinical trials is there is just so much oversight that happens for these clinical trials. Every document, every procedure, is scrutinized by multiple committees. There’s a scientific review committee, there’s a review board, IRB, that reviews these. Many of these trials are reviewed by the FDA and they’re reviewed by your doctor and your doctor’s colleagues that are also participating in the trial. So, every detail is discussed at length.

In fact, a lot of the times there’s a lot more structure to being on the clinical trial than just routine clinical care because they’ve thought so thoroughly about when everything needs to be done and what the right timing of is for the various procedures.

Katherine Banwell:    

Right. And another concern that people have is; clinical trials are my last resort treatment option. What do you say to that Dr. Pollack?

Dr. Seth Pollack:       

Yeah, no. That’s a common misconception. So, we like to have clinical trials for every phase of the patient’s cancer journey because we’re trying to make every single part of the cancer journey better. So, I think a lot of people think that, okay, when they hit their last resort that’s kind of the time to try something new. Even in the very earliest parts of the cancer journey, even in the diagnosis phase sometimes we’ll have clinical trials where we’ve tried different images, modalities, or look at things in a different way in terms of the biopsies.

But then, in terms of the cured-of treatments, when somebody is in the cured-of setting we don’t usually try something very brand new. But a lot of the times we’ll try something that is very affective for patients at the end, and we want to try and make the cured-of strategy even better. So, a lot of the times for those patients we’ll have new therapies that are very safe and established that we’re trying to incorporate earlier into patients’ treatments because we know they work really well, right? And then, even in patients who have incurable cancer a lot of times it’s better to try a clinical trial earlier on just because sometimes the clinical trials have the most exciting new therapies that are bringing people a lot of hope.

And a lot of the times you want to try that when you’re really fit and when you’re in good shape. So, that’s why I think that you really want to think about doing a clinical trial when the opportunity arises.

Katherine Banwell:    

Yeah. Beause it could be beneficial to you and it’s certainly going to be beneficial to other people. Is this fact or fiction; it will be expensive? Dr. Pollack?

Dr. Seth Pollack:       

That’s fiction because the way the clinical trials work is we go through everything very carefully to figure out what things are standard and what things are unique to the clinical trials. So, if you are getting chemotherapy, you’re going to need blood work, you’re going to need the chemotherapy drugs, you’re going to need some sort of imaging, CT scan, or whatever your doctor would do.

And all those sorts of things are considered standard, so your insurance company is built for those. Then there’s a bunch of things that are considered research. For example, there’s special research bloodwork, maybe there’s an investigational agent that’s being added to standard chemotherapy. Those things are billed to the study, so you don’t actually have to pay anything extra, it’s just like you’re getting the normal treatment as far as you’re concerned. I mean, that’s the way it always is, and I haven’t had any of my patients ever get into real problems in terms of the finances of these things. It always works very straight forward like standard therapy.

Katherine Banwell:    

Okay. That’s good to know. The logistics will be a nightmare and I don’t live close to a research hospital. Sujata, did you have that issue?

Sujata Dutta:  

Yeah. That’s a very interesting one, and actually I’ll share my experience. I did have this concern about logistics, because I got my transplant at Mayo Rochester, which is a two-hour drive from where I live. And so, when I got to know about it literally me and my husband were like, “Oh, my gosh. What are we going to do?” It’s not just me, my husband is my caregiver, he has to take the day off to drive me to Mayo, wait through my treatment, and drive me back. Then we have boys who were distance learning at the time, and so what do we do with them? Do we drop off a friends or take a favor from a friend? And so on and so forth.

So, the logistics was an issue and we literally said, “Thanks but no thanks” and we walked out of the room. And we came downstairs, and my husband was like, “What the heck?” My team understands everything, and I fortunately work for a very good employer, and they understand everything, people first. And so, he was like, “I can figure this out. Let’s do it if this is what’s going to help you, then let’s just figure this out.” And at that time, it was so good, and I have total respect for Dr. Pollack.

You and everybody in this medical community. My doctor who leads the trial at Mayo, she actually said, “Why don’t you check with your local cancer center? Maybe they are also approved by FDA, and they may be able to administer this treatment to you.” Unfortunately, at that time they weren’t but we were like, “We’re going to go ahead with the trial. It doesn’t matter.” My husband was like, “I’ll take the day off, you don’t worry about it.” And then, four months later my institute did get approved by FDA, and so I was able to transfer from Mayo to my local cancer center, Abramson Cancer Center, which is 20 minutes from home. And so, there are options, I know that it can be an issue and it can be overwhelming at the time which was the case with me. But I was able to overcome that, so maybe there are options available that the patients can consider.

Katherine Banwell:    

Yeah. Dr. Pollack, do you have anything to add?

Dr. Seth Pollack:       

No. I think the logistics and the location are real concerns with clinical trials.

Clinical trials do sometimes require you to have an extra visit, sometimes they’re a little bit less flexible in terms of when you can get your medication. If you’re getting a standard treatment your doctor may say, “It’s probably okay for you to wait an extra week.” Whereas sometimes on a clinical trial, not always, but sometimes they could be a little bit more strict about when you’re supposed to get certain things. And likewise, with the travel for some people that can be an issue. I mean, the clinical trial is not available everywhere. I mean, Sujata was very lucky that she was able to do the clinical trial she was doing close to home, but that doesn’t always happen. So, I think that’s an important thing to talk to your clinical team about.

Katherine Banwell:    

Yeah. Some patients feel that clinical trials aren’t safe, is that the case, Dr. Pollack?

Dr. Seth Pollack:       

No. I mean, we go through, as I was saying before, these clinical trials are extensively vetted. So, the safety is, of course, one of the things that we look most carefully about. But as I was saying before, like with any treatment’s cancer treatments have toxicity, that’s a common problem. So, and when you’re dealing with something brand new sometimes there is a little bit more risk. So, when you’re talking about these very early-stage Phase I trials you probably want to talk to your doctor about what sorts of toxicities you can expect and where they are in the Phase I trial. Are you the first ever to receive this new drug? And if you are nobody’s making you go in the clinical trial, so it can only help to get more information. Right? So, you should ask your team about it, you should find out.

Most of the time there’s going to be a lot of patients that have been treated already, I mean, they can’t give you definitive data about how things are going but they can maybe say, “Hey. I’ve already treated a few patients on it, and they seem to be doing great.”

Katherine Banwell:    

So, you need to weigh the pros and cons of the trial.

Dr. Seth Pollack:       

You do need to weigh the pros and cons. Now, when you’re talking about these Phase IIs and Phase IIIs, I mean, these are drugs now that have really been vetted for their safety and we have a lot of data about it. And even the Phase Is, it’s not like these things are coming out of nowhere, they’ve been scrutinized, we really expect that they’re going to be safe but we’re doing the trial to prove it. So, it’s a good thing to ask about.

Katherine Banwell:    

Yeah, yeah.

Sujata Dutta:  

Yeah. I would also add that it’s so closely monitored that safety is a top priority, it’s front and center. So, the advantage, I think, with being on a trial is the close monitoring of the patient exactly for this reason.

If something is amiss it’s going to be picked up as quickly as possible and you’re any issues are going to be addressed as soon as. So, I think, safety does get addressed pretty quickly.

Katherine Banwell:    

Good, good. Okay. That’s good to know. Another concern is; I’ll get a placebo. Dr. Pollack, what is a placebo first of all? And is that true in a clinical trial setting?

Dr. Seth Pollack:       

So, there are clinical trials with placebos, it’s a real thing. And what a placebo is, it’s a pill and it’s made to look just like the real pill, but it doesn’t have any active drug in it. Sometimes people say it’s a sugar pill, but it may or may not be sugar, but it’ll probably be something without a taste. But it’s an inert substance that is not going to affect you at all.

And your doctor won’t know whether you’re getting a placebo or not, so a lot of the times they’ll call these things double-blind because your doctor doesn’t know, your pharmacist doesn’t know. And to unblind you they have to go through special procedures to find out whether you’re on the studied drug or not.

Katherine Banwell:    

Would a placebo be given solely? Or would it be given in addition to this new drug that’s being tested?

Dr. Seth Pollack:       

Yeah. So, it’s unusual for a placebo to be given solely. Usually there’ll be a clinical trial where you’re getting the standard treatments plus the new drug or standard treatment plus the placebo, so no matter what you’re getting the standard treatments. There are still some trials where, and these are usually for patients with very advanced cancer, who there’s not really any treatment options that are good. Where they will randomize people to just be on the standard drug versus the placebo.

Sometimes what they’ll do is if they want to do a trial that’s the standard drug versus a placebo, they’ll do the imaging very frequently and they’ll have a crossover. So, a crossover means that everybody gets to be on the new drug, but some people will have to go on the placebo first. So, and then they watch you very closely. So, if you get randomized to go on the placebo and your cancer starts to grow, they figure it out very quickly and then they give you the opportunity to go on the new drug.

Katherine Banwell:    

I see, okay. I’ll be stuck in the trial forever and I can’t change my mind. Sujata, did that happen to you?

Sujata Dutta:  

No. I mean, when I finally agreed and signed the dotted line it was made very clear to me that it was voluntary, I was volunteering to be part of the trial and I could get out of the trial at any point of time. So, in my case I’m in Phase III of a trial, the first commitment was for two years and then the next was five years.

So, again, it sounds daunting to me right now, two years is coming to an end in July of this year. I’m like, “Wow! Two years are over already?” And then five years, I’m not thinking about that, but again, it was at any point I could just say that I’ve had enough, or whatever be the reason, I could get out of the trial. So, no. Yes. There’s an option.

Katherine Banwell:    

Can data from trials even be trusted? Dr. Pollack, is that the case?

Dr. Seth Pollack:       

Well, of course, I mean, it can be trusted. Because the thing with the clinical trial data is that you really see the data and there’s all kinds of scrutiny making sure that the data is reported accurately. Now, there’s a whole other conversation we could have as to whether we could interpret the data differently. And sometimes that is an issue that comes up, but the data is reported very accurately.

So, and there are statistics that are very well understood, and the bar is actually pretty high to say one arm of the trial was better than the other arm of the trial. So, if patients have better survival on one arm, if we say that, usually it means they did considerably better. Enough better that it wasn’t a random chance that one extra patient did better on the treatment arm. No. There were enough patients that did better that the statisticians can go through it with a fine-toothed comb. And they can be absolutely sure up to exactly how many percent sure they can tell you, 0.05 percent or less chance of error that this was a real difference between the study arm and the standard of care arm.

Sujata Dutta:  

I think you mentioned too that one is trust, and one is data. So, Dr. Pollack mentioned a lot about the data, I think the trust is also a very important thing. I like to go with positive intent because I do not have a reason to believe my doctor has some ulterior motive to suggest a clinical trial. And so, I trust them wholeheartedly. The first hurdle is you have to trust the system or what is being proposed to you because, as Dr. Pollack said, it’s gone through a lot of vetting. A recommendation to be part of a trial itself is vetted by your doctor when they make the recommendation. So, have faith, trust, that they are making a good recommendation. And then, of course, the data, I don’t know much about that, but as I said, I trust it. So, I would trust the data too.

Katherine Banwell:    

Of course. Of course. Some patients feel like they’re going to lose their privacy. Sujata, did you feel that at all?

Sujata Dutta:  

No. Not at all.

I mean, with everything else that is also taken care of, my information, or whatever, is not made available to anybody. And so, obviously there’s a lot of people will get those, and I had a huge pile of paperwork to go through, but I think that’s a good thing. For my peace of mind that I knew that my information was not going to be shared outside of the study, the trial, etc., and things. So, no, I don’t think that’s a problem.

Katherine Banwell:    

Beyond these misconceptions is there anything else you hear? Dr. Pollack?

Dr. Seth Pollack:       

Well, I hear a lot of people really interested in clinical trials. I mean especially, I treat some patients with rare cancers or with unusual presentations and I think people are very excited to be a part of something that could be new, that could be the next wave. A lot of times the clinical trials have new things with the most exciting science that could be the future of treatment.

So, I think a lot of people are excited about clinical trials. And I also hear some of the reservations that you’re expressing. I think usually when patients ask their questions are very straightforward and easy to address so that people can make their own decisions.

Katherine Banwell:    

Dr. Pollack, I’d like to go back to you and ask you the same question about privacy. Do patients need to be worried about that?

Dr. Seth Pollack:       

No. I mean, look, in our crazy modern world there’s concerns everywhere, but the clinical trial is very, very careful. Whenever possible we use the medical chart.

And then, we have a very stringently protected database that’s storing people’s information, but it’s deidentified. So, I mean, we have a separate key to figure out who the patients are and then we try to limit the use of the patient’s name or any identifying information about them beyond that. So, and your information is not shared. For example, if there’s a drug company involved in the trial, your information is not shared with the drug company, you have a new identifier that is unique and not traceable back to you that is provided to whoever, if there’s outside groups working on the trial with you. So, your information is very carefully protected, and everyone is very conscious about issues regarding privacy.

Katherine Banwell:    

That’s great to know. Sujata, there’s clearly a lot of hesitation and misconceptions out there. What would you say to someone who’s considering a trial but is hesitant?

Sujata Dutta:  

I would say speak to your provider, speak to your doctor, and get all these myths kind of busted to say, “it’s going to be expensive” or whatever those questions are. And then, through that process also try and understand what is it that the study is trying to achieve? How is that going to be beneficial to you? So, in my instance, it wasn’t the last line of defense, it was just one of the processes or combos that would help me. And so, that was important for me to understand and then a little bit of education as well. So, I was asking, I have questions on my phone every time I meet my provider, and I did the same thing. So, I think that one of the good practices is keep your note of your questions and have those questions ready. And no question is silly, all questions are important. So, ask as many questions as you can and use that opportunity to educate yourself about it.

And maybe you realize, “No. I don’t think it’s working for me” or “I don’t think this trial is good for me.” But it’s good, important, to have that conversation with your provider, that’s what I would recommend highly.

Katherine Banwell:    

Excellent. Thank you, Dr. Pollack, if someone is interested in participating, how can they find out about what trials are even available for them?

Dr. Seth Pollack:       

Yeah. I mean, the best thing to do is to start just by asking your doctor if they know about any clinical trials. And a lot of the times the clinical trials are run at the big medical centers that may be closer to you, so you could ask your doctor if there’s any clinical trials at the big medical center even. Or I always think it’s good to get a second opinion, you could go get a second opinion at the big medical center that’s close to you and ask them what clinical trials are at your center.

And sometimes they’ll be conscious about some of the clinical trials that may be even run around the country. And you can ask about that as well.

Katherine Banwell:    

Would specialists have more information about clinical trials than say a general practitioner?

Dr. Seth Pollack:       

So, I specialize in rare cancers, so a lot of the times the general practitioners they’ve got my cell phone number, and they text me, and they say, “Hey, do you have a clinical trial going on right now?” And that happens all the time, but yeah, the specialists will usually because frankly there’s so much to know. And the general practitioners really have a lot to keep track of with all the different types of diseases that are out there. Whereas at the big centers, the specialists, part of their job is really to keep their tabs on what’s going on with the clinical trials.

So, they’re good people to ask, either your local doctor could reach out to them, or you could go get a second opinion and ask.

Sujata Dutta:  

There’s also a lot of information, Katherine, on sites such as LLS, or PEN, or American Cancer Society that they also publish a lot of information. Of course, I would recommend once you have that information then vet it by your specialist, or whatever. But if you’re interested in knowing more about clinical trials in general and some that would work for you, then those are also some places to get information from.

Katherine Banwell:    

That’s great information. Thank you, I was going to ask you about that Sujata. Well, before we end the program, Dr. Pollack, I’d like to get your final thoughts. What message do you want to leave the audience with related to clinical trial participation?

Dr. Seth Pollack:       

Yeah. I think clinical trials it can be a very rewarding thing for a lot of patients to do, I think patients really like learning about the new treatments. And I think a lot of patients really like being a part of pushing the therapies forward in addition to feeling like sometimes they’re getting a little bit of an extra layer of scrutiny, because there’s a whole extra team of research coordinators that are going through everything.

And getting access to something that isn’t available yet to the general population. So, I think there’s a whole host of advantages of going on clinical trials, but you need to figure out whether or not a clinical trial is right for you.

Katherine Banwell:    

Yeah. Sujata, what would you like to add?

Sujata Dutta:  

Absolutely, I second everything that Dr. Pollack is saying. And in my personal experience I wouldn’t say everything is hunky-dory, everything is fine. I’m going through treatment, I have chemo every four weeks, I started with chemo every week. That’s when the logistics pace was really difficult because going to Mayo every week was not easy. But anyways, as the trial progress itself every four weeks, but as I said the benefits are huge because I have labs every four weeks. I meet my provider every four weeks.

So, we go through the labs and anything amiss, I’ve had some changes to my dosage because I’ve had some changes in the labs. And so, there’s a lot of scrutiny which I like, but the flip side, for maybe some maybe like, “I have to have chemo every four weeks. Do I want to do that or not?” Or whatever. In my case, I knew it, and I signed up for it, and I’m committed to doing that for two years. And so, I’m fine with that. So, I would say all in all, I’d see more benefits of being in a clinical trial. One, you’re motivated to give back to the community. Two, you are being monitored and so your health is important to your provider just as it is to you. And so, I highly recommend being part of a trial if it works for you and if you’re eligible for one.

Katherine Banwell:    

Yeah. Sujata Dutta, and Dr. Pollack, thank you both for taking the time to join us today.

Sujata Dutta:   

Thank you.

Dr. Seth Pollack:       

Thank you.

Katherine Banwell:    

And thank you to all of our partners. To access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell, thanks for joining us.  

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Patient Profile: Jeff’s Diagnosis of Parotid Cancer

On April 27, 2020, I received an email plea for help from Debra after she had read my book. Deb’s husband, Jeff, was struggling with a very malignant form of parotid cancer called Acinic Cell Carcinoma that, despite surgery and radiation, had spread to his chest and spine. Worse yet, there were no clear treatment choices available. Over the next 11 months, Deb & I have maintained an almost constant contact via emails and telephone chats. It has been my honor & privilege to get to know Deb. I am most impressed by her innate intelligence, rock solid determination and steadfast perseverance. Jeff is alive today primarily due to Debra’s tireless efforts to find a solution. 

On my request, Deb has penned this story of Jeff’s illness. I sincerely hope that it will inspire other patients and caregivers to become more empowered. Remember, Knowledge is Your Superpower.  Sajjad Iqbal, M.D.


 My husband, Jeff, was diagnosed with high-grade acinic cell cancer of the parotid gland in February of 2018 at the age of 65. He was a very young, healthy 65, who rarely saw a doctor and needed no regular medications. For 37 years he was a teacher and coach at a small school in Iowa. We have now been married for 47 years, have three children and three grandchildren. Jeff retired early from teaching when he was 61, but continued coaching for several more years. He also did small construction jobs with our son. We spent a lot of time traveling by car throughout the United States. It was a shock to both of us to hear that Jeff had this disease since he seemed to be so healthy. 

Several years before Jeff was diagnosed, he mentioned a small lump behind his ear. During a brief physical he had, he asked his doctor about it and was told to keep an eye on it and, if it got bigger, to see a doctor. In January of 2018, he noticed it was getting bigger so he saw the doctor. He was told he needed to get a biopsy but it was probably just a blocked salivary gland. As soon as I heard that, I figured it was cancer as Jeff’s mother had been diagnosed with salivary gland cancer many years before. Hers was a slow growing adenoid cystic cancer that was treated with surgery only. He had his biopsy done at a local hospital and when they said it was cancer, we had them make him an appointment at Mayo Clinic in Rochester, Minnesota which is only a couple of hours from our home. 

He had further testing done at Mayo which also showed a lesion at the top of his spine. In March of 2018, he had two separate surgeries to remove the tumors. Cancer was also found in 9 of 21 lymph nodes. He came through the surgeries with no problems. Soon after, he received six weeks of radiation on both of those spots. This was much tougher on him than the surgeries. His neck was badly burned, nausea, no appetite, etc. He made it through and slowly got back to feeling normal. At that time, we were told that chemo wouldn’t help him so he never received any. Three months later, a scan showed a nodule on his chest wall. They did a biopsy and found it to be the same type of cancer. He had a cyroablation on that spot.

Two months later, we found out that the cyroablation had not worked, the spot was bigger and there were several spots on bone. He had Foundation One testing done on his tumor and it showed very few mutations. There was only one mutation, RET, that had a possible treatment at that time. There was a clinical trial at Mayo for a targeted drug for that mutation and they were able to get him in. He started on that in February of 2019. He experienced no side effects and the chest wall tumor stayed about the same the entire time he was on the trial. Unfortunately, though, it was not stopping the bone mets. He had radiation three days in a row on a couple of them when they started causing him pain. Because it was not stopping the bone mets, he discontinued the trial. His oncologist told us that he didn’t know of any clinical trials at that time that would help him. The only thing he had to offer was chemo and possibly Keytruda but he was doubtful they would help very much. Needless to say, this left us feeling lost as to what to do next. 

The Mayo oncologist had told us that, in his opinion, clinical trials were the best way to go as you could get the newest treatments and you would be closely monitored. That is what I decided to look for first. Luckily, since Jeff was first diagnosed, I had been doing research on his cancer and possible treatments. There wasn’t a lot as it is a rare cancer. I have no medical background but was determined to figure things out as much as I could and find something that might be able to help. I found three clinical trials that I thought might work for Jeff. These trials did not exist when Jeff was first diagnosed. I sent them to his Mayo oncologist who had told me that he would be willing to look over a clinical trial if I found one. He agreed that the one I was most interested in looked like a good possibility and one of the trial locations was Iowa City which is about 3 hours from us. This is a trial that focuses on the genetic makeup of the cancer instead of the type of cancer. One of the mutations that Jeff has is FANCA and this trial was the first one I found where FANCA was one of the mutations they were looking for. Also, Jeff’s mother, who also had salivary gland cancer, is a carrier of the FANCA gene. There is no known relationship between the FANCA gene and salivary gland cancer but I feel there must be a connection. It is a rare cancer and to have a mother and son have it must be extremely rare. Our children have been tested for this gene and we discovered that our son is also a carrier. 

It was in February of 2020 when we went to Iowa City to try to get Jeff into the trial. We found out that they had changed the requirements for the trial and now you had to have had chemo in order to be accepted. The doctor started Jeff on the oral chemo drug, Xeloda, and told us that if anything grew, he would stop the chemo and try to get him in the trial. Jeff was also having some rib and back pain and that was treated with five days of radiation therapy. Following those treatments, he had some heartburn issues for a couple of weeks after which it slowly resolved.

At first, the chemo wasn’t too bad. Soon though, there were many nasty side effects; peeling palms and bottoms of feet, nausea, no appetite, etc. He did not feel up to doing much and spent a lot of time sitting or lying down. He was on this about five months and decided to stop due to the side effects. He was having some back pain during his chemo and was prescribed a narcotic pain reliever. It helped the pain some, but caused constipation, so he had to take more medication for that. He told the doctors he did not like taking the narcotic drug and wanted to find another alternative. They tried one drug and the first night he took it he ended up fainting and having make a trip to the hospital. Needless to say, we stopped that drug right away! They said he was having nerve pain from his spine but were not able to find the exact source. He ended up having a vertebroplasty on his spine as they thought it might help his pain.

Unfortunately, it didn’t help the pain and he also started having a weird feeling of a tight band around his abdomen. We made a trip back to the Mayo Clinic to see a pain specialist there. He thought Jeff might be helped with a nerve block on either side of his spine. He had this done and, not only did it not help, it made the band feeling we were trying to get rid of feel even tighter! This was very disheartening as we really thought it would help. Iowa City had started him on Gabapentin for his nerve pain and had been slowly increasing the dosage. He was also started on a low dose of Lexapro and, between those two drugs, he started to feel less pain in his back. The “band” feeling is still there, but not as bad as it once was. He was finally able to get into the clinical trial in August of 2020. The drug he is on now is a parp inhibitor that targets the FANCA pathway. He has been on this drug for about seven months now with almost no side effects. The targeted tumor has shrunk quite a bit and the bone mets have stayed the same. Unfortunately, on his last scans, there was a new spot on his liver. He was allowed to stay in the trial as it is working on his targeted tumor and he is scheduled soon for microwave ablation on his liver. 

When one treatment stops working, I always look for a new clinical trial first.

It is hard, however, as so many of the trials are for certain types of cancer. Even though you discover (from the mutations) that a certain drug may help your cancer, you can only be in that trial if you have a certain type of cancer. I hope in the future there are many more trials based on the genetic makeup of the cancer rather than the type of cancer. The other problem is that the majority of trials are held at larger hospitals that are just too far away to go back and forth as often as needed. It would be great if there were a way to have some of the treatments done at a larger hospital in your own state. Also, if you have a rare cancer, it is much harder to find clinical trials. 

I have a library background and have always relied on books and articles to find information about various topics. Now that the internet is available that has been my most important tool at this time. Also, websites like PEN, providing patient’s stories, healthy recipes and classes are very helpful. These types of sites have really helped me feel not so alone and have given me much more hope than I have ever received from any oncologist. It is also over the internet that I connected with Dr. Sajjad Iqbal after reading his book “Swimming Upstream.” He has been very generous with his time and willing to give suggestions and advice as he has a cancer similar to Jeff’s. It has been a great comfort to me to be able to e-mail him to get his opinion on something or ask a question. He has also helped me feel more hopeful than anyone else I have talked to – not only by his words but by his courageous example. 

When Jeff was first diagnosed, he was still coaching track. The entire track team wanted to have a benefit for him and sold t-shirts and wristbands, and had a meal and dodge ball tournament to raise money for him. Jeff is a very popular guy in this rural school district and I know it meant a lot that his team did this for him. We have support from our family and friends and feel that we have people we can call if we need something. The pandemic has kept us from getting together with people as often as we would like but we are looking forward to that in the future. 

We know that there is a good chance that Jeff’s cancer may never be cured. If that is true, I would like the next best thing – for him to live as long as possible, as well as possible with the cancer. We have had three very good years living with it and working around his medical appointments. I will do everything I can to help him have more of those years. 

Jeff has handled this whole situation very well from the beginning. He is a pretty laid-back person who takes things as they come and isn’t much of a worrier. He has kind of set an example for me just by taking things as they come. I feel his job is to fight the cancer and my job is to help him fight the cancer. Our lives are pretty much the same as they were before he was diagnosed – only with a lot more doctor appointments! 

What You Need to Know Before Choosing a Cancer Treatment

What You Need to Know Before Choosing a Cancer Treatment from Patient Empowerment Network on Vimeo.

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What steps could help you and your doctor decide on the best treatment path for your specific cancer? This animated video explains how identification of unique features of a specific cancer through biomarker testing could impact prognosis, treatment decisions and enable patients to get the best, most personalized cancer care.


If you are viewing this from outside of the US, please be aware that availability of personalized care and therapy may differ in each country. Please consult with your local healthcare provider for more information.


Related Programs:

 

PEN-Powered Activity Guides

Digitally Empowered™


TRANSCRIPT:

Dr. Jones:

Hi! I’m Dr. Jones and I’m an oncologist and researcher. I specialize in the care and treatment of patients with cancer. 

Today we’re going to talk about the steps to accessing personalized care and the best therapy for YOUR specific cancer. And that begins with something called biomarker testing.

Before we start, I want to remind you that this video is intended to help educate cancer patients and their loved ones and shouldn’t be a replacement for advice from your doctor.

Let’s start with the basics–just like no two fingerprints are exactly alike, no two patients’ cancers are exactly the same. For instance, let’s meet Louis and another patient of mine, Ben. They both have the same type of cancer and were diagnosed around the same time–but when looked at up close, their cancers look very different.  And, therefore, should be treated differently.

We can look more closely at the cancer type using biomarker testing, which checks for specific gene mutations, proteins, chromosomal abnormalities and/or other molecular changes that are unique to an individual’s disease.

Sometimes called molecular testing or genomic testing, biomarker testing can be administered in a number of ways, such as via a blood test or biopsy. The way testing is administered will depend on YOUR specific situation.

The results could help your healthcare team understand how your cancer may behave and to help plan treatment. And, it may indicate whether targeted therapy might be right for you. When deciding whether biomarker testing is necessary, your doctor will also take into consideration the stage of your cancer at diagnosis.

Louis:

Right! My biomarker testing results showed that I had a specific gene mutation and that my cancer may respond well to targeted therapy.

Dr. Jones, Can you explain how targeted therapy is different than chemo?

Dr. Jones:

Great question! Over the past several years, research has advanced quickly in developing targeted therapies, which has led to more effective options and better outcomes for patients.

Chemotherapy is still an important tool for cancer treatment, and it works by affecting a cancer cell’s ability to divide and grow. And, since cancer cells typically grow faster than normal cells, chemotherapy is more likely to kill cancer cells.

Targeted therapy, on the other hand, works by blocking specific mutations and preventing cancer cells from growing and dividing.

These newer therapies are currently being used to treat many blood cancers as well as solid tumor cancers.  As you consider treatments, it’s important to have all of the information about your diagnosis, including biomarker testing results, so that you can discuss your treatment options and goals WITH your healthcare team.

Louis:

Exactly–Dr. Jones made me feel that I had a voice in my treatment decision. We discussed things like potential side effects, what the course of treatment looks like and how it may affect my lifestyle.

When meeting with your healthcare team, insist that all of your questions are answered. Remember, this is YOUR life and it’s important that you feel comfortable and included when making care decisions. 

Dr. Jones:

And, if you don’t feel your voice is being heard, it may be time to consider a second—or third—opinion from a doctor who specializes in the type of cancer you have. 

So how can you use this information to access personalized treatment?

First, remember, no two cancers are the same. What might be right for someone else’s cancer may not work for you.

Next! Be sure to ask if biomarker testing is appropriate for your diagnosis. Then, discuss all test results with your provider before making a treatment decision. And ask whether testing will need to be repeated over time to identify additional biomarkers.

Your treatment choice should be a shared decision with your healthcare team. Discuss what your options and treatment goals are with your doctor.

And, last, but not least, it’s important to inquire about whether a targeted therapy, or a clinical trial, might be appropriate for you. Clinical trials may provide access to promising new treatments.

Louis:

All great points, Dr. Jones! We hope you can put this information to work for you. Visit powerfulpatients.org to learn more tips for advocating for yourself.

Dr. Jones:

Thanks for joining us today. 


This program is supported by Blueprint Medicines, and through generous donations from people like you.

Barriers to Clinical Trial Participation

 

What are some of the barriers to clinical trial participation? What is a virtual clinical trial? Should my doctor be speaking to me about my clinical trial options? Dana Dornsife, founder of Lazarex Cancer Foundation, speaks to the key barriers in trials and how COVID-19 has really opened the door for a lot of opportunity to engage with patients around clinical trials.

Barriers to Clinical Trial Participation

Barriers to Clinical Trial Participation from Patient Empowerment Network on Vimeo.

What is a Virtual Clinical Trial?

What is a Virtual Clinical Trial? from Patient Empowerment Network on Vimeo.

COVID and Clinical Trials

COVID and Clinical Trials: Has There Been a Shift? from Patient Empowerment Network on Vimeo.

Tomorrow’s Medicine Today

 

From PEN-Powered Activity Guide V, beloved medical oncologist Dr. Bora Lim of The University of Texas MD Anderson Cancer Center walks us through what a clinical trial is, the phase of how drugs get approved, and how the pandemic crisis has amplified the criticality of clinical trials.

What is a Clinical Trial?

What is a Clinical Trial? from Patient Empowerment Network on Vimeo.

How Do Drugs Get Approved?

How Do Drugs Get Approved? from Patient Empowerment Network on Vimeo.

Will Pandemic Transform Future of Clinical Trials?

Will Pandemic Transform Future of Clinical Trials? from Patient Empowerment Network on Vimeo.

Clinical Trials as an Empowerment Tool

Clinical Trials as an Empowerment Tool from Patient Empowerment Network on Vimeo.

Head and Neck Cancers

This was originally posted by the National Cancer Institute here.


What are cancers of the head and neck?

Cancers that are known collectively as head and neck cancers usually begin in the squamous cells that line the moist, mucosal surfaces inside the head and neck (for example, inside the mouth, the nose, and the throat). These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. Head and neck cancers can also begin in the salivary glands, but salivary gland cancers are relatively uncommon. Salivary glands contain many different types of cells that can become cancerous, so there are many different types of salivary gland cancer.

Cancers of the head and neck are further categorized by the area of the head or neck in which they begin. These areas are described below and labeled in the image of head and neck cancer regions.

Oral cavity: Includes the lips, the front two-thirds of the tongue, the gums, the lining inside the cheeks and lips, the floor (bottom) of the mouth under the tongue, the hard palate (bony top of the mouth), and the small area of the gum behind the wisdom teeth.

Pharynx: The pharynx (throat) is a hollow tube about 5 inches long that starts behind the nose and leads to the esophagus. It has three parts: the nasopharynx (the upper part of the pharynx, behind the nose); the oropharynx (the middle part of the pharynx, including the soft palate [the back of the mouth], the base of the tongue, and the tonsils); the hypopharynx (the lower part of the pharynx).

Larynx: The larynx, also called the voicebox, is a short passageway formed by cartilage just below the pharynx in the neck. The larynx contains the vocal cords. It also has a small piece of tissue, called the epiglottis, which moves to cover the larynx to prevent food from entering the air passages.

Paranasal sinuses and nasal cavity: The paranasal sinuses are small hollow spaces in the bones of the head surrounding the nose. The nasal cavity is the hollow space inside the nose.

Salivary glands: The major salivary glands are in the floor of the mouth and near the jawbone. The salivary glands produce saliva.

Head and neck cancer regions. Illustrates location of paranasal sinuses, nasal cavity, oral cavity, tongue, salivary glands, larynx, and pharynx (including the nasopharynx, oropharynx, and hypopharynx).

Credit: Terese Winslow

Cancers of the brain, the eye, the esophagus, and the thyroid gland, as well as those of the scalp, skin, muscles, and bones of the head and neck, are not usually classified as head and neck cancers.

Sometimes, cancerous squamous cells can be found in the lymph nodes of the upper neck when there is no evidence of cancer in other parts of the head and neck (1). When this happens, the cancer is called metastatic squamous neck cancer with unknown (occult) primary. More information about this cancer type can be found in Metastatic Squamous Neck Cancer with Occult Primary (PDQ®).

What causes cancers of the head and neck?

Alcohol and tobacco use (including smokeless tobacco, sometimes called “chewing tobacco” or “snuff”) are the two most important risk factors for head and neck cancers, especially cancers of the oral cavity, oropharynx, hypopharynx, and larynx (25). At least 75% of head and neck cancers are caused by tobacco and alcohol use (6). People who use both tobacco and alcohol are at greater risk of developing these cancers than people who use either tobacco or alcohol alone (68). Tobacco and alcohol use are not risk factors for salivary gland cancers.

Infection with cancer-causing types of human papillomavirus (HPV), especially HPV type 16, is a risk factor for some types of head and neck cancers, particularly oropharyngeal cancers that involve the tonsils or the base of the tongue (911). In the United States, the incidence of oropharyngeal cancers caused by HPV infection is increasing, while the incidence of oropharyngeal cancers related to other causes is falling (9). More information is available at the HPV and Cancer page.

Other risk factors for cancers of the head and neck include the following:

Paan (betel quid). Immigrants from Southeast Asia who use paan (betel quid) in the mouth should be aware that this habit has been strongly associated with an increased risk of oral cancer (1213).

Preserved or salted foods. Consumption of certain preserved or salted foods during childhood is a risk factor for nasopharyngeal cancer (1415).

Oral health. Poor oral hygiene and missing teeth may be weak risk factors for cancers of the oral cavity (1617). Use of mouthwash that has a high alcohol content is a possible, but not proven, risk factor for cancers of the oral cavity (1617).

Occupational exposure. Occupational exposure to wood dust is a risk factor for nasopharyngeal cancer (1415). Certain industrial exposures, including exposures to asbestos and synthetic fibers, have been associated with cancer of the larynx, but the increase in risk remains controversial (18). People working in certain jobs in the construction, metal, textile, ceramic, logging, and food industries may have an increased risk of cancer of the larynx (19). Industrial exposure to wood or nickel dust or formaldehyde is a risk factor for cancers of the paranasal sinuses and nasal cavity (2022).

Radiation exposure. Radiation to the head and neck, for noncancerous conditions or cancer, is a risk factor for cancer of the salivary glands (162324).

Epstein-Barr virus infection. Infection with the Epstein-Barr virus is a risk factor for nasopharyngeal cancer (25) and cancer of the salivary glands (2627).

Ancestry. Asian ancestry, particularly Chinese ancestry, is a risk factor for nasopharyngeal cancer (1415).

What are the symptoms of head and neck cancers?

The symptoms of head and neck cancers may include a lump or a sore that does not heal, a sore throat that does not go away, difficulty in swallowing, and a change or hoarseness in the voice. These symptoms may also be caused by other, less serious conditions. It is important to check with a doctor or dentist about any of these symptoms. Symptoms that may affect specific areas of the head and neck include the following:

Oral cavity. A white or red patch on the gums, the tongue, or the lining of the mouth; a swelling of the jaw that causes dentures to fit poorly or become uncomfortable; and unusual bleeding or pain in the mouth.

Pharynx. Trouble breathing or speaking; pain when swallowing; pain in the neck or the throat that does not go away; frequent headaches, pain, or ringing in the ears; or trouble hearing.

Larynx. Pain when swallowing or ear pain.

Paranasal sinuses and nasal cavity. Sinuses that are blocked and do not clear; chronic sinus infections that do not respond to treatment with antibiotics; bleeding through the nose; frequent headaches, swelling or other trouble with the eyes; pain in the upper teeth; or problems with dentures.

Salivary glands. Swelling under the chin or around the jawbone, numbness or paralysis of the muscles in the face, or pain in the face, the chin, or the neck that does not go away.

How common are head and neck cancers?

Head and neck cancers account for approximately 4% of all cancers in the United States (28). These cancers are more than twice as common among men as they are among women (29). Head and neck cancers are also diagnosed more often among people over age 50 than they are among younger people.

Researchers estimated that more than 65,000 men and women in this country would be diagnosed with head and neck cancers in 2017 (29).

How can I reduce my risk of developing head and neck cancers?

People who are at risk of head and neck cancers―particularly those who use tobacco―should talk with their doctor about ways that they may be able to reduce their risk. They should also discuss with their doctor how often to have checkups. In addition, ongoing clinical trials are testing the effectiveness of various medications in preventing head and neck cancers in people who have a high risk of developing these diseases. Descriptions of these clinical trials can be accessed by searching NCI’s list of cancer clinical trials. NCI’s list of cancer clinical trials includes all NCI-supported clinical trials that are taking place across the United States and Canada, including the NIH Clinical Center in Bethesda, MD.  For information about other ways to search the list, see Help Finding NCI-Supported Clinical Trials.

Information specialists from NCI’s Cancer Information Service (CIS) can also help people find clinical trials for the prevention of head and neck cancers. The CIS can be reached at 1–800–4–CANCER (1–800–422–6237) or by chatting with a cancer information specialist online through LiveHelp.

Avoiding oral HPV infection may reduce the risk of HPV-associated head and neck cancers. However, it is not yet known whether the Food and Drug Administration-approved HPV vaccines Gardasil®, Gardasil 9®, and Cervarix® prevent HPV infection of the oral cavity, and none of these vaccines has yet been approved for the prevention of oropharyngeal cancer. More information about these vaccines is in the NCI fact sheet Human Papillomavirus (HPV) Vaccines.

How are head and neck cancers diagnosed?

To find the cause of the signs or symptoms of a problem in the head and neck area, a doctor evaluates a person’s medical history, performs a physical examination, and orders diagnostic tests. The exams and tests may vary depending on the symptoms. Examination of a sample of tissue under a microscope is always necessary to confirm a diagnosis of cancer.

If the diagnosis is cancer, the doctor will want to learn the stage (or extent) of disease. Staging is a careful attempt to find out whether the cancer has spread and, if so, to which parts of the body. Staging may involve an examination under anesthesia (in an operating room), x-rays and other imaging procedures, and laboratory tests. Knowing the stage of the disease helps the doctor plan treatment.

How are head and neck cancers treated?

The treatment plan for an individual patient depends on a number of factors, including the exact location of the tumor, the stage of the cancer, and the person’s age and general health. Treatment for head and neck cancer can include surgery, radiation therapy, chemotherapy, targeted therapy, or a combination of treatments.

People who are diagnosed with HPV-positive oropharyngeal cancer may be treated differently than people with oropharyngeal cancers that are HPV-negative. Recent research has shown that patients with HPV-positive oropharyngeal tumors have a better prognosis and may do just as well on less intense treatment. An ongoing clinical trial is investigating this question.

More information about treatment for specific types of head and neck cancers is in the following PDQ® cancer treatment summaries, which are available in patient and health professional versions, as well as in Spanish (the links below go to the patient versions in English):

The patient and the doctor should consider treatment options carefully. They should discuss each type of treatment and how it might change the way the patient looks, talks, eats, or breathes.

What are the side effects of treatment?

Surgery for head and neck cancers often changes the patient’s ability to chew, swallow, or talk. The patient may look different after surgery, and the face and neck may be swollen. The swelling usually goes away within a few weeks. However, if lymph nodes are removed, the flow of lymph in the area where they were removed may be slower and lymph could collect in the tissues, causing additional swelling; this swelling may last for a long time.

After a laryngectomy (surgery to remove the larynx) or other surgery in the neck, parts of the neck and throat may feel numb because nerves have been cut. If lymph nodes in the neck were removed, the shoulder and neck may become weak and stiff.

Patients who receive radiation to the head and neck may experience redness, irritation, and sores in the mouth; a dry mouth or thickened saliva; difficulty in swallowing; changes in taste; or nausea. Other problems that may occur during treatment are loss of taste, which may decrease appetite and affect nutrition, and earaches (caused by the hardening of ear wax). Patients may also notice some swelling or drooping of the skin under the chin and changes in the texture of the skin. The jaw may feel stiff, and patients may not be able to open their mouth as wide as before treatment.

Patients should report any side effects to their doctor or nurse, and discuss how to deal with them.

Where can I find more information about clinical trials for patients with head and neck cancers?

Clinical trials are research studies conducted with people who volunteer to take part. Participation in clinical trials is an option for many patients with head and neck cancer. Ongoing clinical trials are testing the effectiveness of treatments for head and neck cancers. Descriptions of these clinical trials can be accessed by searching NCI’s list of cancer clinical trials, which includes all NCI-supported clinical trials that are taking place across the United States and Canada, including the NIH Clinical Center in Bethesda, MD. For information about other ways to search the list, see Help Finding NCI-Supported Clinical Trials.Alternatively, call NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for information about clinical trials for individuals with head and neck cancer, or chat with a cancer information specialist online through LiveHelp.

People interested in taking part in a clinical trial should talk with their doctor. Information about clinical trials is available in the NCI publication Taking Part in Cancer Treatment Research Studies. This resource describes how research studies are carried out and explains their possible benefits and risks.

What rehabilitation or support options are available for patients with head and neck cancers?

The goal of treatment for head and neck cancers is to control the disease, but doctors are also concerned about preserving the function of the affected areas as much as they can and helping the patient return to normal activities as soon as possible after treatment. Rehabilitation is a very important part of this process. The goals of rehabilitation depend on the extent of the disease and the treatment that a patient has received.

Depending on the location of the cancer and the type of treatment, rehabilitation may include physical therapy, dietary counseling, speech therapy, and/or learning how to care for a stoma. A stoma is an opening into the windpipe through which a patient breathes after a laryngectomy, which is surgery to remove the larynx. The National Library of Medicine has more information about laryngectomy in MedlinePlus.

Sometimes, especially with cancer of the oral cavity, a patient may need reconstructive and plastic surgery to rebuild bones or tissues. However, reconstructive surgery may not always be possible because of damage to the remaining tissue from the original surgery or from radiation therapy. If reconstructive surgery is not possible, a prosthodontist may be able to make a prosthesis (an artificial dental and/or facial part) to restore satisfactory swallowing, speech, and appearance. Patients will receive special training on how to use the device.

Patients who have trouble speaking after treatment may need speech therapy. Often, a speech-language pathologist will visit the patient in the hospital to plan therapy and teach speech exercises or alternative methods of speaking. Speech therapy usually continues after the patient returns home.

Eating may be difficult after treatment for head and neck cancer. Some patients receive nutrients directly into a vein after surgery or need a feeding tube until they can eat on their own. A feeding tube is a flexible plastic tube that is passed into the stomach through the nose or an incision in the abdomen. A nurse or speech-language pathologist can help patients learn how to swallow again after surgery. The NCI booklet Eating Hints: Before, During, and After Cancer Treatment contains many useful suggestions and recipes.

Is follow-up care necessary? What does it involve?

Regular follow-up care is very important after treatment for head and neck cancer to make sure that the cancer has not returned, or that a second primary (new) cancer has not developed. Depending on the type of cancer, medical checkups could include exams of the stoma, if one has been created, and of the mouth, neck, and throat. Regular dental exams may also be necessary.

From time to time, the doctor may perform a complete physical exam, blood tests, x-rays, and computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scans. The doctor may monitor thyroid and pituitary gland function, especially if the head or neck was treated with radiation. Also, the doctor is likely to counsel patients to stop smoking. Research has shown that continued smoking by a patient with head and neck cancer may reduce the effectiveness of treatment and increase the chance of a second primary cancer.

Additional information can be found at NCI’s Follow-Up Medical Care page.

How can people who have had head and neck cancers reduce their risk of developing a second primary (new) cancer?

People who have been treated for head and neck cancers have an increased chance of developing a new cancer, usually in the head, neck, esophagus, or lungs (30–32). The chance of a second primary cancer varies depending on the site of the original cancer, but it is higher for people who use tobacco and drink alcohol (30).

Especially because patients who smoke have a higher risk of a second primary cancer, doctors encourage patients who use tobacco to quit. Information about tobacco cessation is available from NCI’s Cancer Information Service at 1–800–4–CANCER (1–800–422–6237) and in the NCI fact sheet Where To Get Help When You Decide To Quit Smoking. The federal government’s main resource to help people quit using tobacco is BeTobaccoFree.gov.The government also sponsors Smokefree Women, a website to help women quit using tobacco, and Smokefree Teen, which is designed to help teens understand the decisions they make and how those decisions fit into their lives. The toll-free number 1–800–QUIT–NOW (1–800–784–8669) also serves as a single point of access to state-based telephone quitlines.


Selected References

  1. Mendenhall WM, Mancuso AA, Amdur RJ, et al. Squamous cell carcinoma metastatic to the neck from an unknown head and neck primary site. American Journal of Otolaryngology 2001; 22(4):281–287.

    [PubMed Abstract]

  2. Gandini S, Botteri E, Iodice S, et al. Tobacco smoking and cancer: a meta-analysis. International Journal of Cancer 2008; 122(1):155–164.

    [PubMed Abstract]

  3. Hashibe M, Boffetta P, Zaridze D, et al. Evidence for an important role of alcohol- and aldehyde-metabolizing genes in cancers of the upper aerodigestive tract. Cancer Epidemiology, Biomarkers and Prevention 2006; 15(4):696–703.

    [PubMed Abstract]

  4. Hashibe M, Brennan P, Benhamou S, et al. Alcohol drinking in never users of tobacco, cigarette smoking in never drinkers, and the risk of head and neck cancer: pooled analysis in the International Head and Neck Cancer Epidemiology Consortium. Journal of the National Cancer Institute 2007; 99(10):777–789.

    [PubMed Abstract]

  5. Boffetta P, Hecht S, Gray N, Gupta P, Straif K. Smokeless tobacco and cancer. The Lancet Oncology 2008; 9(7):667–675.

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  6. Blot WJ, McLaughlin JK, Winn DM, et al. Smoking and drinking in relation to oral and pharyngeal cancer. Cancer Research 1988; 48(11):3282–3287.

    [PubMed Abstract]

  7. Tuyns AJ, Estève J, Raymond L, et al. Cancer of the larynx/hypopharynx, tobacco and alcohol: IARC international case-control study in Turin and Varese (Italy), Zaragoza and Navarra (Spain), Geneva (Switzerland) and Calvados (France). International Journal of Cancer 1988; 41(4):483–491.

    [PubMed Abstract]

  8. Hashibe M, Brennan P, Chuang SC, et al. Interaction between tobacco and alcohol use and the risk of head and neck cancer: pooled analysis in the International Head and Neck Cancer Epidemiology Consortium. Cancer Epidemiology, Biomarkers and Prevention 2009; 18(2):541–550.

    [PubMed Abstract]

  9. Chaturvedi AK, Engels EA, Pfeiffer RM, et al. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. Journal of Clinical Oncology 2011; 29(32):4294–4301.

    [PubMed Abstract]

  10. Adelstein DJ, Ridge JA, Gillison ML, et al. Head and neck squamous cell cancer and the human papillomavirus: summary of a National Cancer Institute State of the Science Meeting, November 9–10, 2008, Washington, D.C. Head and Neck 2009; 31(11):1393–1422.

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  11. Gillison ML, D’Souza G, Westra W, et al. Distinct risk factors profiles for human papillomavirus type 16-positive and human papillomavirus type-16 negative head and neck cancers. Journal of the National Cancer Institute 2008; 100(6):407–420.

    [PubMed Abstract]

  12. Ho PS, Ko YC, Yang YH, Shieh TY, Tsai CC. The incidence of oropharyngeal cancer in Taiwan: an endemic betel quid chewing area. Journal of Oral Pathology and Medicine 2002; 31(4):213–219.

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