Kate Hutcheson, Ph.D. Hi, I'm Dr. Kate Hutcheson, professor of Head and Neck Surgery and chief of the section of Speech Pathology and Audiology at MD Anderson Cancer Center. I'm here today with Dr. Dave Fuller, professor of Radiation Oncology, and this is the Cancerwise Podcast. Dr. Fuller, thank you so much for being here today. Today we'll be talking about managing the side effects of head and neck cancer treatment and the way that supportive care can really make a difference in the outcomes of our patients and the quality of the care that we provide. So, we'll be talking about head and neck radiotherapy, of course, and this is one of the more challenging treatments that people can go through because it affects such vital parts of who we are, how we eat, how we talk, sometimes how we look. And you know, I want to think a little bit about that in the context of supportive care today.  

Clifton David (Dave) Fuller, M.D., Ph.D. Yeah, you know, I think it's so important, just as you mentioned, because radiation therapy, which most head and neck cancer patients will receive, affects so many parts of what we use for eating, swallowing, speaking, etc. And while it's a very effective therapy, during treatment and long after, there can be these effects that are really important. So, I think that as, you know, as we're gonna be exploring, how do we minimize the side effects become really important? I think as a key member of the team and as a speech pathologist, one of the most critical things is how do we maintain and preserve those important eating and swallowing functions that are so critical to so many parts of our life? So, I guess I would kind of start by saying, when a patient's coming for head and neck cancer radiotherapy, they know that they're gonna get radiation, how do you start to prepare them?          

Kate Hutcheson, Ph.D. I mean, you certainly sort of summarized it briefly in the right way, which is I'm a speech pathologist and the first thing I'm going to focus on for a patient going through head and neck radiation is how to help the patient preserve their swallow function. And this sort of overriding philosophy that we use in that space is this concept of use it or lose it. And that idea is just to keep the throat muscles, keep the swallowing muscles active through the process to preserve their function. We know that there are, as you know, sort of unavoidable injuries to the tissues, the muscles, the nerves, the soft tissue in the swallowing system that can make swallowing painful, can make swallowing slow or weak. But the concept of use it or lose it is that we don't want to layer on top of that unnecessary loss of function from disuse, right? Like I often use with a patient, the arm in a cast analogy, if you've ever had your in a cast or a kid in your household with an arm in a cast, when you take that cast off, there's visible atrophy and loss of function just because that muscle has been immobilized. And so the idea with our supportive care is preparing the patient with that mindset of keeping the system active throughout their therapy. That's what they can do. That's the way we can empower them to have an influence on their outcome, their results.  

Clifton David (Dave) Fuller, M.D., Ph.D. I guess, you know, one thing, Kate, I'd wanna, you know, highlight that you just mentioned there is how far that philosophy is, which you've just raised from what I was trained with.  

Kate Hutcheson, Ph.D. Yeah.  

Clifton David (Dave) Fuller, M.D., Ph.D. You know, 15 years ago and I think in many places today, there was this philosophy that, well, patients are just not gonna be able to swallow during therapy. The side effects from the radiation acutely in terms of irritation of the mucus membranes are gonna be too severe. Let's just put a feeding tube in everybody.  

Kate Hutcheson, Ph.D. Right.  

Clifton David (Dave) Fuller, M.D., Ph.D. Let's just make sure that everyone has a feeding tube so that they don't have to swallow because we won't be able to get them to. Can you just kind of sidetrack for a second and talk about how we've moved to your philosophy where the goal is really this preservation of this function and not just kind of a nihilism about everyone's gonna need a feeding tube.  

Kate Hutcheson, Ph.D. Yeah, I mean, I think there's two elements in the way that we support patients that have evolved in the 20 years I've been here doing this. And one surrounds feeding or eating through radiation, and the other is around the role of sort of exercising the swallow systems. Those are sort of questions at the heart of the PRO-ACTIVE trial that we collaborate on. Let's start with the feeding and eating. When I started here, when we started here, about 70% of patients going through head neck radiotherapy would have a feeding tube inserted early in the course of that treatment or even before the treatment with the idea that they wouldn't be able to eat through their treatment. And over time, we have really moved toward more of a reactive model of inserting feeding tubes, as you know, to try to promote ongoing swallowing activity. A key element of that, in my opinion, is making sure that we know going into the radiation treatment that the swallowing system is intact to achieve that goal. And so we partner and collaborate, as you know, a lot on making sure that patients get a swallow evaluation before their radiation treatment even starts.  

Clifton David (Dave) Fuller, M.D., Ph.D. That baseline assessment to know where we are before we get started.  

Kate Hutcheson, Ph.D. Exactly. Let's benchmark it. Before we say, 'Hey, you got to keep eating,' let's make sure that when you're eating, it's not going into your lungs. And what we see on those baseline assessments is the vast majority of patients have the ability to eat through treatment. They may need subtle modifications, and that's what the speech pathologist will help them with is how can you eat through treatment most safely, most effectively, but that's a real key ingredient in the, in the process. I don't know, you've been here for a long time. What do you see as the evolution with the feeding tube?  

Clifton David (Dave) Fuller, M.D., Ph.D. Yeah, I think there's been, in my practice time here, there's a been a large shift, because initially, this idea was, well, the vast majority of patients are gonna need a feeding tube.  

Kate Hutcheson, Ph.D. Right.  

Clifton David (Dave) Fuller, M.D., Ph.D. That has moved to now a subset of patients are gonna a needing tube, but even more important, the subset of the patients who need a feeding tube, how do we minimize their time on tube, right? So, it's become this evolution where it's a gradation of I would say a kind of therapeutic optimism, right? That our patients are not necessarily gonna need feeding tubes and we don't have to kind of give up ahead of time. We can individualize each patient's, based on their baseline assessment, we can individualize each patient's care and we can adapt each patient's care in a very unique way. That there's not a kind of intuitive way to know ahead of the time exactly who's gonna turn out where, but if we have a good baseline assessment, we can risk assess them effectively.  

Kate Hutcheson, Ph.D. What is your philosophy? What's your strategy for deciding if and when on a feeding tube?  

Clifton David (Dave) Fuller, M.D., Ph.D. So, I have a very pragmatic philosophy for kind of on-treatment management. First off, if a patient is in significant impairment up front, I think, you know, we're already, our hands are already tied. The majority of the groups of patients we kind of come into, we say is, what is your baseline swallowing and nutritional status now? If we can get patients through the majority of treatment with effective nutritional support, that really becomes something that's very adaptive. So, we're looking at week-to-week changes. So, when a patient comes in and if they've had a weight loss of more than a couple of kilograms, a couple times in a row, we know where our trajectory is. But even these small decrements in oral intake or small decrements in weight early are key indicators about what's gonna happen. So, if I have a patient who's undergoing six weeks of radiation, and in the second week, they're already describing to me that they're having problems getting enough food, they're already described that they can't get the food down, we know that it's a crisis, even though it hasn't met the criteria for a feeding tube. So, I think that kind of high intensity, high temporal frequency monitoring really becomes key. So, I would say philosophically, my triggers are two weeks of two kilograms of weight loss or more, loss of 5% body weight over the entire interval of radiation or an acute period of more than 24 hours where they have, you know, disrupted intake. And it doesn't seem like they're gonna be recoverable with ancillary supportive care.  

Kate Hutcheson, Ph.D. And about what percentage of your patients at this point?  

Clifton David (Dave) Fuller, M.D., Ph.D. I would ballpark something between 15 and 25%. I would say that's probably, you know, it very much depends on the volume of radiation. It very much depends on the location of the radiation. You know, if we're covering large areas of the back of the throat, if we are covering large areas of the front of the mouth, it's much more challenging. That said, you now, again, you, know, I think philosophically, part of what we're also relying on is this kind of interplay with the rest of the team, because if we're seeing a patient going into decrement, Speech Pathology evaluates them and says, 'Hey, they've got a solid swallow. This is really a pain control issue.' We're gonna optimize on that.  

Kate Hutcheson, Ph.D. Right.   

Clifton David (Dave) Fuller, M.D., Ph.D. On the other hand, if we were seeing that there's, you know, aggressive swallowing dysfunction that needs to be remediated, sometimes you do have to put in a feeding tube just because you have to do it. So, I think that's kind of, philosophically, it's an adaptive strategy for every patient, and so you may have some knowledge of the 25% is a number for a group, right? But an individual has a binary risk that's their own. So, I guess, you know, one of the things that I would kind of also ask about or think about, you know we talk about these side effects, you're talking to a patient at the initial interview, you're doing their baseline assessment. It's not just we want you to swallow. Can you talk about some of the knock-on or secondary effects of swallowing dysfunction after therapy that you're trying to prevent? So, it's not just we want to avoid a feeding tube. What happens, what's the larger kind of scope of the impact?  

Kate Hutcheson, Ph.D. I think you're talking about, you know, the impact of swallowing difficulties, both during treatment and after, and I think that I very regularly remind myself that we think about this from a clinical perspective, but that eating is part of this bigger sort of part of who we are. Like, we enjoy meals with friends and family. We enjoy the experience of eating, even if it's done by ourselves, because food tastes good. You know, so there's this whole part of it that it's really wrapped up into the enjoyment of everyday living and I'll leave that there and from a clinical perspective what I would say is that what we think about is that we know that individuals who have swallowing difficulty, even in mild degrees, will have elevated risk of secondary health problems, right? And they're sort of obvious if you think about the chain of how the swallow connects to everything else in our health but you know one would be malnutrition, micronutrient deficiencies. We've actually counter-intuitively recently found in a research study that patients who have really severe swallowing difficulty actually have better micronutrion intake, and we think it's because they have to consolidate and just eat what's healthy.  

Clifton David (Dave) Fuller, M.D., Ph.D. Yeah, yeah.  

Kate Hutcheson, Ph.D. So, sometimes there is a counter-intuitive.  

Clifton David (Dave) Fuller, M.D., Ph.D. Like a densification of their food.  

Kate Hutcheson, Ph.D. Yeah, like nutrient-dense, nutrient-dense smoothies or soups, because it takes a lot of effort to get it in, whereas you or I or somebody who has the luxury of eating well, we choose what we like, unless we're more disciplined. But the other aspect that I think is maybe less familiar to the general population is that swallowing also interacts very significantly with our respiratory health. Because one of the consequences of a swallowing problem can be aspiration, things going into the lungs when you eat and drink. When that happens in large volumes, it's uncomfortable. It causes you choking and coughing. But more frequently in our population, as you know, is the development of chronic small volume aspiration where a little bit of what you're swallowng is going the wrong way most of the time. And that over time can lead to an elevated risk of aspiration pneumonias. Aspiration pneumonias lead to hospitalizations, and those survivors we've seen in population-level data who develop aspiration pneumonia have an elevated risk of death compared to their peers who don't develop that problem. So, part of why we get in there to try to intervene early and sort of preserve the swallow is because we all enjoy eating and we wanna help facilitate that enjoyment for our patients, but the other part is that we want them to avoid these secondary complications of their cancer that are related to side effects and not the disease itself.  

Clifton David (Dave) Fuller, M.D., Ph.D. I think that's I think it's so critical because you know, we've we've also seen in in data that especially for patients who've lost muscle mass, the placement of feeding tube seems to be a co-factor that's related to greater risk of cancer and non-cancer death, right? So, you know, it's got effects, it's got effects that go far beyond just, you know, what's happening on treatment. And I think sometimes it's very important when we meet with patients in those initial interviews to emphasize how important this is because it's over an incredibly long period of potential survival for many of these patients. So, we're trying to say, you know, 'Hey, it would be easier if you had a feeding tube. We wouldn't have to have you do these swallowing exercises and give you this pain management and do all these things. But the reason that we're doing this is because we have a vision of you as a survivor. We are already projecting into your feature state a assessment of your risk and we want to protect you from these long-term side effects of swallowing dysfunction that are much, much bigger than just, I'm not eating during the six weeks of radiation,' right? That there's this immediate interval, but we're thinking about that long- term window. And so, I think that becomes something, at least as a clinician, really important because then when we're looking at something like the PRO-ACTIVE trial, how does that guide, how does it help us think about what we should do in an interventional manner to optimize care for these patients over the long term. And there's, you know, I think it's, if you could lay out the premises of the trial, because it's something that there's some ambiguity about, right?  

Kate Hutcheson, Ph.D. So, the PRO-ACTIVE trial is a conceptually sort of unique type of trial because it's a phase IV effectiveness design. And I know that this is not a research methodology podcast so I won't get in the weeds. But the idea of that is you're at the final end of the road of testing an intervention or something that has already shown in like really controlled smaller trials that there's efficacy when you do this in a controlled setting. And so lots of times in a, in a trial that is an effectiveness trial, what you're looking at is there's no control arm. Everyone's receiving some active level of intervention, but you're really looking at if there's a preferred way to achieve the goal or to deliver a therapy. So, with PRO-ACTIVE we had these two sort of like fundamental elements of therapy. One was eating as a swallow preservation strategy and we used a program called Eat All Through Radiation, EAT-RT. We like acronyms. And then the other element of the therapy was swallowing exercises. And these are sort of long-held, sort of, parts of proactive swallowing therapy that is used to help a patient use it or lose it to preserve their swallow. What we did on the trial, we randomized close to 1,000 patients across North America. So, there were about 13 institutions that contributed, ours included. And patients were randomized to receive those eat and exercise therapies and varying, at various time points, so what we were modulating was the timing or the intensity of the swallowing therapy that you got during radiation. The goal was to see, you know, does delivering more intensive earlier intervention result in less days on a feeding tube or other outcomes, but ultimately a lot of it surrounded the goal of understanding how, if it matters, how you help a patient use it or lose it, if there's a more effective way to do it. Or whether it's sort of dealer's choice for like whatever works for your patient, your environment. Like what flexibility is available in helping people preserve their swallow?  

Clifton David (Dave) Fuller, M.D., Ph.D. Yeah, you have a couple of good interventions we know from strong data are effective. Now the question is, how do you practically...  

Kate Hutcheson, Ph.D. How do you implement them in the clinic?  

Clifton David (Dave) Fuller, M.D., Ph.D. Implement these in some kind of large scale.  

Kate Hutcheson, Ph.D. Exactly. And the goal is that, you know, we'll be able to answer sort of the fundamental question of a pragmatic trial is, is there a preferred method to achieving this goal? And so that's what we'll able to see.  

Clifton David (Dave) Fuller, M.D., Ph.D. Do you feel like as you were designing and executing this study, you've got this large scale pragmatic exercise, within the larger community, what has been the thought or response about these to date? Does each place just have their own formula? Or is it something where there's large degrees of agreement or camps that feel like, well, this is an accepted practice. Do you feel like where will this move the needle in terms of the consensus within the community, you think?  

Kate Hutcheson, Ph.D. I think that there is a general consensus on the value of swallow preservation through promoting activity of the pharynx during radiation. I think that fundamentally I see when I'm out in the community or out practicing that people get behind that. I think there's a lack of consensus on how you accomplish that goal and what the data from the trial will be able to help is to provide sort of a sense of whether there can be flexibility or whether there truly is a better way to do it. At the end of the day, I think some of the key ingredients are pretty simple as far as like what, fundamentally, no matter how you use it or lose it, what needs to be in place. I think one critical thing that we already sort of talked about is a collaborative sort of philosophy of feeding tube utilization that promotes, regardless of whether you need a feeding tube to get through your treatment, the idea that you still need swallow activity, like we still need to swallow despite a feeding tube. I think that's one. I think the second one is, and it's really critical, we also spoke about it is the baseline evaluation. Are we trying to preserve an intact swallow or are we needing to more intensely sort of help a patient through radiation when they already have a swallowing impairment because of the disease itself? And those are two different goals. And the only way we know the answer to that goal and the right approach is with a baseline.  

Clifton David (Dave) Fuller, M.D., Ph.D. Is this is this tumor-associated problems with swallowing the radiation might even improve or is this radiation-induced dysphasia problems with you know dysfunction that we're trying to ameliorate.  

Kate Hutcheson, Ph.D. Exactly. Outside of that, I do think that the key ingredients will come down to still sort of the basic fundamentals. Like there are two main swallow preservation activities. One of them is exercising the swallow muscles. One them is eating. And how you sort of help patients accomplish those goals and when is what the trial will answer.  

Clifton David (Dave) Fuller, M.D., Ph.D. So, you know, Kate, one of the things that I want to emphasize is the PRO-ACTIVE program that the entire premise is predicated on this idea of a multisciplinary team that includes trained speech pathologists and baseline evaluations. It really is kind of, you know, embedded within this concept that there's a multidisciplinary team managing these patients. I think as a physician, it's important that we emphasize that that really is a core component of care, that if you're getting head and neck care and you're expecting to get the kind of the results that we would see from the study, it's imperative that there's a speech pathologist seeing you at the time of diagnosis. And that may not be the standard of care at many places. But moving forward for those places that are embedded in this kind of multidisciplinary ecosystem and have those resources, how do you see the results of the trial are gonna change practice within the larger community.  

Kate Hutcheson, Ph.D. I think that the goal is that the trial will be able to help facilities look at their resources, look at the patients and say, like, how do we want to implement a model of use it or lose it therapy? Because every one of the arms of the trial is helping patients keep the swallowing system active during radiation in a different way. And so, for me, the goal is that we make it more approachable. For instance, we've published, we have under peer review, the therapy manual so that clinicians can actually see, like, no, no really, what does it mean to do this? And multidisciplinary team members as well, you know, because it's not just about having the speech pathologist in that multidisciplinary team, it's nutrition, dental oncology, social work, you name it. Head and neck cancer is a team sport. The patient, their caregiver, everyone on that team has to be sort of harmonized and solidified into the ultimate goal. Do you think fundamentally that you'll change the way that you talk to patients about their on-treatment interval or their supportive care based on the trial?  

Clifton David (Dave) Fuller, M.D., Ph.D. So, that's a great question, because one of the things I think that when we talk to patients we really emphasize is that there's this criticality of speed, right? And speed in terms of communication with your care team. I think as we look at the study and we say, OK, how are we going to intervene? When are we gonna make those decisions? It's all very, very, very, very dependent on what we see in real time with that patient. So, you know, if a patient is able to reach out to their speech language pathologist, as they're able to reaching out to the nutritionist, they're able to reach to the physician and say, 'Hey, it's Monday, something has changed with my swallowing from Friday.' The lead time and advantage that that gives us is huge, regardless of which of these approaches that the health system really feels is most effective. So, we can think of the trial as something that applies to the larger group of patients, but to the individual patients, my advice is the same, is let us, as the care team, know what you're doing so that we can make effective decisions quickly and effectively and preserve your, as close to an organic swallow as we possibly can. So, I think in a certain sense, it will change what we do. I don't think it's gonna change as much what we tell the patients in that, you know, we're here and we don't know what's gonna happen to you as an individual patient. We're gonna do everything we can to maximize your capacity to maintain and preserve that swallow, rather than trying to lose and regain that function. So, I think that narrative stays true, but I think what we're gonna do at a macro sense may, may certainly change, right? Our process level may change, but I think at the individual patient, they're still gonna get that same kind of mantra about the need for.  

Kate Hutcheson, Ph.D. An ounce of prevention.

Clifton David (Dave) Fuller, M.D., Ph.D. Right, correct, correct. And just high, high-attentive, adaptive care.  

Kate Hutcheson, Ph.D. Exactly. What makes you excited on the horizon for, sort of, toxicity reduction, meaning less side effects, when delivering effective head and neck radiation?  

Clifton David (Dave) Fuller, M.D., Ph.D. Well, I think one of the things that we're seeing, you know, in many studies is that the rate of feeding tubes is dropping. We're seeing radiotherapy techniques that are, I would argue, much more effective at reducing some of these doses to these swallowing muscles that are causing these problems. But I also am a little disheartened, because even in those de-intensification studies, we're still seeing levels of dysphasia. We're still seeing levels of feeding tube that are higher than what we'd want. And I think, again, it goes back to that individual idea that, okay, when it was 70% of patients getting feeding tubes, well, we felt really bad about that. Now that it's closer maybe to 30 or less, 15, 25 even in some subselected subset populations. We don't go, well, that's just great, because we still know that that's a sub-.  

Kate Hutcheson, Ph.D. We still want it to be zero.  

Clifton David (Dave) Fuller, M.D., Ph.D. We want it be zero.  

Kate Hutcheson, Ph.D. Yeah. Exactly!  

Clifton David (Dave) Fuller, M.D., Ph.D. So, I think we're moving the bar, but I think there's a lot of potential improvement for us to have.  

Kate Hutcheson, Ph.D. It's an exciting time and we have a lot to accomplish together to get it to zero, right?  

Clifton David (Dave) Fuller, M.D., Ph.D. Exactly.  

Kate Hutcheson, Ph.D. That's right. Well thanks so much for being here, I look forward to continued improvements for our patients and it's been great having this discussion with you today. Thanks for listening to the Cancerwise Podcast from MD Anderson Cancer Center. If you've enjoyed this episode, don't forget to follow or subscribe on Apple Podcasts, Spotify, YouTube or wherever you get your podcasts, and be sure to comment or review. For more information or to request an appointment at MD Anderson, call 1-877-632-6789, or visit MDAnderson.org.