Tina Kaczor, ND, FABNO, recently sat down with Dugald Seely, ND, MSc, FABNO, director of the Ottawa Integrative Cancer Centre, to discuss several ongoing studies in integrative oncology. Studying integrative oncology has unique study design challenges. They talked about how these challenges are met and how current study designs are attempting to accurately reflect complex in-office care. Seely covered a broad range of topics, from details of specific studies to an overview of the current landscape of collaborating with peers in integrative oncology. He also offered some tips on how private practice clinicians can begin to participate in research.
One of Seely’s current research endeavors is the Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial. Seely says it’s probably the most interesting and complex study his team is currently working on. The goal of this trial is to explore the impact of naturopathic medicine in addition to conventional usual care at the hospital for patients who have thoracic cancers and are eligible for surgery.
The researchers are randomizing a group of these patients into receiving standard usual care at the hospital only, or getting usual care plus an integrated approach delivered by a naturopathic doctor before surgery and for a year after surgery. They’ll be looking at a whole battery of different outcomes, including adverse events related to surgery, quality-of life-measures, immune function, inflammatory changes, cost-effectiveness, and, ultimately, long-term survival and recurrence rate over 5 years.
Seely sees this study as an opportunity to investigate the effectiveness of truly holistic, whole-person care. To do that, they’ll be employing interventions in 4 domains:
At the end of the study, Seely expects to be able to say whether, as a whole, naturopathic medicine in this setting can make a difference in outcomes related to survival or adverse events related to surgery.
Another study Seely is working on is called the Canadian/US Integrative Oncology Study. This is being done in partnership with Bastyr University. The other principal investigator is Leanna Standish, ND, PhD, LAc, FABNO.
This study, which will be conducted over a 6- to 7-year period, will recruit and observe the interventions given to patients with 4 types of late-stage cancer. The researchers will look at the naturopathic care interventions given to these patients at 11 different clinics across North America.
Seely and the research team are looking at clinics with the most innovative and useful therapies in naturopathic oncology. They’ll document the interventions and follow the patients to observe effects on survival rates. In addition, they’ll be looking at cost and quality of life.
In the end, Seely hopes the CUSIOS trial will shed light on the outcomes we see with patients who go through these advanced integrative oncology clinics.
For clinicians interested in getting involved in research, Seely offered this guidance: Build relationships. For him, doing graduate work was key because it automatically caused him to engage and collaborate with others. If you’re interested in research, start by connecting with people at academic institutions and begin the dialog.
If you’d like to learn more about the sites currently involved in integrative medicine research, visit Clinicaltrials.gov.
Dugald Seely, ND, MSc, FABNO, leads the clinical practice and cancer research program for the Ottawa Integrative Cancer Centre. In addition to his clinical role as a naturopathic doctor, he also serves as the executive director of research & clinical epidemiology at the Canadian College of Naturopathic Medicine, affiliate investigator for the Ottawa Hospital Research Institute, and vice president for the Oncology Association of Naturopathic Physicians. Seely completed his master of science in cancer research at the University of Toronto and is a fellow of the American Board of Naturopathic Oncology. As a clinician scientist, Seely has been awarded competitive grant and trainee funding from the Canadian Institutes of Health Research, the Canadian Breast Cancer Research Alliance, the SickKids Foundation, the Lotte and John Hecht Memorial Foundation, the Ottawa Regional Cancer Foundation, and the Gateway for Cancer Research Foundation.
Tina Kaczor, ND, FABNO: Hello. I'm Tina Kaczor with the Natural Medicine Journal. I'm speaking today with naturopathic physician and researcher, Dugald Seely. Dr. Seely is the founder and executive director of the Ottawa Integrative Cancer Center in Ontario, Canada. He has led numerous research projects including the largest integrative naturopathic cancer care clinical trial ever conducted in North America. He has more than 50 MEDLINE indexed peer-reviewed publications. Last but not least, among his many accolades over the years, he has most recently been awarded the Dr. Rogers Prize, which is a prize awarded in Canada for excellence in complementary medicine. Dr. Seely, thanks so much for joining me today.
Dugald Seely, ND, FABNO: Thanks so much for having me on to talk, Tina.
Kaczor: There are so many things that we could talk about in the realm of research. You're also a practicing clinician, so there's lots we could discuss. I want to start off with a couple projects that are currently ongoing for you, maybe that you're knee-deep in. If you could just start us off with a couple research projects that you have going on these days.
Seely: Yeah. Sure. One of the ones that you mentioned, the integrative oncology study, is a big study that we're doing. That's probably the most interesting and complex study that we're running right now. I say running a little bit loosely because we actually haven't started it yet. We're waiting on final ethics approval. We're nearing the runway anyways. This is the Thoracic POISE Trial, which is the Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial. The goal for this trial is to explore the impact of naturopathic medicine in addition to conventional usual care at the hospital for patients who have thoracic cancers and are eligible for surgery.
What we're doing in this study is we're going to be randomizing a group of these patients into receiving standard usual care at the hospital only, or getting usual care plus an integrated approach delivered by a naturopathic doctor prior to their surgery and for a year after the surgery as well. We have a whole battery of different outcomes that we're exploring, including adverse events related to surgery. We're looking at quality of life measures. We're looking at some biological surrogates, including immune function, inflammatory changes in the body, and we're looking at some cost-effective outcomes and, ultimately, long-term survival and recurrence rate over 5 years. This study is a long study. It's going to take us probably, by the end of the whole thing, maybe 12 years. We're starting off with a feasibility component to explore the interventions and how effective they can be applied before we move into the randomized component with a much larger population.
Kaczor: That brings up a question in my mind. That is, when you talk about the feasibility aspect, are you designing it such that the intervention will be standardized across the patients, or will this be more naturopathic in it being more personalized per patient in a systems-based approach?
Seely: Yeah. That's a great question. We've struggled a lot with how to develop the intervention in a way that could be representative of naturopathic medicine in the field. Then, also scalable and standardizable in a way that it could be replicated in another trial. I think we balanced it as much as we can from both ends. It depends on who you speak to I suppose around that. The goal is truly holistic or a whole-person care. We have components that relate to the use of targeted natural health products that we've standardized for this population. We've got a nutritional approach that we've standardized to some degree. We have interventions related to improving fitness and pulmonary fitness in particular. Then we have interventions related to mind and body medicine and psychological well-being. Those four domains comprise the types of interventions that we have.
Within each of those, we developed specific interventions that we detailed how this would be applied, and under what conditions, to these patients so that this can be clearly documented. There is a standardized approach that we're using. There is some flexibility in terms of the patients and how they represent in terms of making changes to the intervention. For example, if someone presents with diarrhea, they will be provided with probiotics as well as their core interventions. If they have weight loss, they would get whey protein as well. If they're experiencing mucositis or neuropathy, we'll apply glutamine. There are some things that we can tweak based on symptoms that the patient has.
Initially, at least, everyone in the study is going to get a course of intervention that everyone will receive similar. We don't know what is going to be providing what effect. That's the nature of a pragmatic study like this. We'll be able to say, at the end of the day, that this whole-person approach, what effect does it have on the outcomes that we're looking at. These are important outcomes for these patients regardless. It's a bit of a black box at the end of the day. We won't be able to identify what specific intervention has what effect, but we can say, as a whole, naturopathic medicine in this setting can make a difference in outcomes related to survival or adverse events related to surgery. Things like duration of hospitalization after surgery, so we'll have information on that.
Kaczor: This particular trial is being done in conjunction with area cancer centers and your center specifically. This is site-specific. Is that right?
Seely: It is initially. The feasibility study, which won't be randomized, is going to happen with the Ottawa Hospital as the hospital site. Then, the Ottawa Integrative Cancer Center (OICC) will be the site where the naturopathic care will be delivered. Once we have run in a few of them, when we do the randomization, we do plan on having at least 2 additional sites across the country. We have a couple places identified that will be good sources for recruitment. It will take place in other sites as well.
Kaczor: Great. I like the idea of it being a whole-systems approach because that's one of the things that we run into in naturopathic medicine is that the reductionist view of a single agent being studied is never reflective of what we're actually doing. That's great. My understanding is you have another study that has multiple locations. Is that correct?
Seely: Yeah. We're doing another study, which is quite different. It's an observational study called CUSIOS. It's the Canadian/US Integrative Oncology Study. This is being done in partnership with Bastyr University and the other co-PI is Dr. Leanna Standish. Really, we're looking at in this study over a 6- to 7-year period to recruit and observe the interventions that are given to patients with late-stage cancer, 4 types of late-stage cancer. We're looking at what the naturopathic care interventions are being given to these patients at 11 different clinics across North America—5 in Canada and 6 in the United States. Each of these clinics are being led by what one would consider to be a naturopathic oncologist or someone steeped in naturopathic oncology.
We're tying to look at clinics that have some of the best therapies, the most innovative and useful therapies, in the naturopathic oncology realm being given to these patients. We want to look at what those interventions are and we're documenting that using REDCap. Then, we're going to be also following these patients to see what the survival rate is amongst these patients. Then, we're also doing a substudy within that looking at cost and quality of life. Their experience through the care as well in a more of a qualitative kind of a way. Again, a lot of outcomes that we're trying to track, it is observational so it won't have the same sort of subjective biases for sure. It'll give us, I think, a lot of really good information about what the practice of naturopathic oncology is ostensively at its best, and what are some of the outcomes that we're seeing patients go through these advanced integrative oncology clinics.
Kaczor: Yeah. Let me ask you this as far as time horizons. These are both pretty lengthy studies. I have a 2-part question. One, when can we look forward to preliminary results or the first publications coming out of either of these trials? Two, are they registered such that, regardless of how the data shakes out, positive or negative, that it will be published? I understand that once trials are registered in a certain way, the data has to be published at some point.
Seely: Yes. For sure, we will publish regardless of what the outcomes are. The CUSIOS study is ongoing. It is registered under clinicaltrials.gov. Thoracic POISE is not yet registered because we haven't got it through ethics yet. We will be establishing that soon. We will be publishing those, no question. We actually have submitted one publication so far and it's been peer reviewed. This is looking at the intervention development process that we used for thoracic POISE, which is really a collaborative effort with physicians at the hospitals, at the hospital pharmacists, the naturopathic doctors as well. That's being submitted for publication.
We also have information related to the survey. When you survey the whole profession through the Oncology Association of Naturopathic Physicians (OncANP), we wanted to know what were the best interventions, what were people using. That really helped influence the interventions that are being chosen for this study. That's also being submitted for publication. Hopefully, we'll see those out in the literature in the next few months.
Kaczor: Great. I'm going to switch gears just a little bit. You mentioned pharmacists and other doctors at these cancer centers. I guess one question to us out there, whether we're clinicians or we're in the research realm, is collaboration and creating those bridges that are required to really study integrative oncology. My question to you is, how to go about that? Maybe just let me know if, over the years, has it changed? It seems like it would be easier now than say 10 years ago, or even 15 years ago. Can you speak on that a little bit?
Seely: Yeah. I think it has gotten easier. There's more of an openness to doing the evaluations and the studies. We're seeing more interest in research, I would say overall, into naturopathic and complementary approaches to care. There's still certainly resistance that exists. Academics and researchers are much more open to looking at these questions typically than clinicians may be. The interest is really in trying to figure out what works from a research perspective. I do believe it's getting more easy to collaborate in that way. Funding opportunities are not easy for sure. I think that, within the naturopathic community, we know that we have a lot of low-lying fruit from our own intervention palate that it should be researched. There's good reason for it, and there's a lot of [inaudible], and there's some early evidence of benefit. [inaudible] have not been researched adequately in many cases.
In terms of building relationships and trying to engage with others, I found doing graduate work was really helpful. There's an automatic process that you engage with others. There's an expectation to be collaborative, and reaching out to people who are doing research at institutions to say, "You've got a good idea about an intervention that might have some effect." I think people are surprised when there's really a good openness for those questions. I think finding people in academic institutions that have a focus on research is a good place to start and to try to start a dialogue and a relationship really.
Kaczor: Yeah. Let me ask you one last question. That is, if people are interested either in your area geographically or they want to look up the centers that are involved in the US/Canadian collaboration trial, where should they look for more information?
Seely: Clinicaltrials.gov will list all the different sites that are involved in the trial. I think there's more information related to that probably on our website, OICC.ca. Yeah, clinicaltrials.gov will have the information related to that.
Kaczor: Okay. Great. As far as getting funding, this is usually in collaboration. I mean, you have a research background and a masters degree and such, so your advice to clinicians who just have their clinical degree is to collaborate basically and find others who are of the same passion for whatever question is being asked and maybe try for grants in that direction? Is that correct?
Seely: Yeah. I think trying to become part of a team, reaching out to different groups that are involved in research techniques through the colleges. They often have research departments and may have some information related to that. Talking to universities and people there. A really great place to start, I think, in terms of doing research too is publishing case reports. There's more of a drive for case reports in [inaudible]. That's something that is ... I know that the AANP is trying to support more case reports. I think that diving into that and writing up a case report that really clinically just gets someone steep into what the evidence is in the literature around the topic and leads to more investment. It's a more accessible entry point into research I would say.
Kaczor: That's a great bit of advice. We, as clinicians, are always ... Everybody has a few cases that are extraordinary over the years, so that's a good bit of advice, especially within integrative oncology when extraordinary cases do happen. It would be great to document that and see if there's commonalities and create studies like yours around those treatments. That would be incredible. I really appreciate your work, your time with me today. I hope we get to talk again in the near future. Thanks, Dugald.
Seely: Thanks so much, Dr. Kaczor. I totally appreciate the journal and what you're doing with it. Thanks for having me.
Kaczor: Take care.