Clinical Trial: Exercise For Metabolic Dysregulation

This interview, “Clinical Trial: Exercise For Metabolic Dysregulation,” is provided by Grand Rounds in Urology’s content partner, Prostatepedia.

Prostatepedia spoke with her about her clinical trial.

Dr. Dieli-Conwright: : It came about pretty early on when I was a graduate student. I started to read more and more literature that was published about the association between how much someone exercised in their lifetime affected their cancer risk. Particularly back then, it was applied mainly to the breast cancer setting and was mostly epidemiological work. Once I saw that, I thought, well,  I’m an exercise physiologist and exercise could be a way to intervene.

More work started to come out that also suggested that if you exercised it could alter your risk for cancer recurrence. I started to think of ways that we could apply exercise to this population. At that time,  it was a relatively newer field and is now generally called exercise oncology: we apply the field of exercise to a cancer setting. This term usually refers to patients who have already been diagnosed, but that can also include people who maybe are at a higher risk for developing cancer.

I did my postdoctoral training at City of Hope, which is a cancer center in Southern California. That was where I got to see firsthand what the patients were experiencing as they were undergoing chemotherapy and radiation. I started to hear anecdotal feedback from the patients about how treatment was making them feel. What was changing with their bodies and with their behaviors? Then I just started to derive exercise questions related to that.

What is the thinking behind your clinical trial?

Dr. Dieli-Conwright: This study spawned from my interest in the side effects and changes that patients were experiencing as they underwent treatment. For some of the more prevalent cancers like breast, prostate, and colorectal cancer, there is literature to provide evidence that individuals are experiencing what I broadly call metabolic dysregulation,  which encompasses things like gaining weight, insulin resistance,  elevated inflammation, and elevated blood pressure.

Whether they have metabolic dysregulation before diagnosis or whether it develops during treatment, they are at higher risk for experiencing diseases like heart disease, diabetes, and obesity.

In prostate cancer in particular, when men are prescribed androgen deprivation therapy, there are side effects to that therapy that lead to metabolic dysregulation.

If you look at individuals who exercise who have not had cancer, we know that exercise can successfully offset metabolic dysregulation. It can improve insulin resistance. It can reduce body composition changes, etc. We wanted to apply exercise to this particular population so that these patients may also experience the benefits of exercise.

If a man who’s reading this ends up participating, what can he expect to happen step by step?

Dr. Dieli-Conwright: This is a randomized controlled trial. Individuals will be randomized to either the exercise group,  and receive a 16-week, 3 times a week exercise program immediately, or the delayed controlled group. Everybody eventually gets the exercise program, but the “exercise group” gets it first. The delayed controlled group gets the program 16 weeks later.

We ask them to come to our facility, which is here at University of Southern California, to exercise. We pair them one-on-one with a certified cancer exercise trainer. They perform both aerobic and resistance exercises for about one hour every time they come. They perform the exercises in an interval circuit training, high-intensity manner. We’ve done that so that we can really challenge the metabolic systems for energy balance that have been shown to be more effective at targeting metabolic dysregulation as to opposed, for instance,  just walking on a treadmill for 60 minutes. We do a number of tests at the beginning, middle, and end of the 16 weeks. Those tests involve a blood draw so that we can measure glucose and insulin, as well as triglycerides, cholesterol, and markers of inflammation. We measure blood pressure, waist circumference, and body composition so how much muscle and fat the patients have. We also measure bone density. We do a battery of what we call physical function tests: how fast can the man climb upstairs? How fast can he walk six meters? How many times he can sit to stand? We do what we call a cardiopulmonary exercise test to test their maximal fitness and we do a series of strength tests to see how strong their muscles are. We give them a packet of questionnaires about quality of life, fatigue, depression,  and other cancer-related symptoms. We are measuring the whole gamut of health outcomes even though our main focus is on insulin resistance and metabolic dysregulation simply because that’s the precursor to diabetes and heart disease.

We retest those measures at  Week 8 and Week 16. We do follow participants after the 16-week period is over. Regardless of what group they were in, we check on them four months later to see how they’re doing.

Are there any specific eligibility criteria that you want to call attention to?

Dr. Dieli-Conwright: The main thing is that they’re over the age of 18 and that they have been on androgen deprivation therapy for the previous 16 weeks. That’s just so that we can allow the medication to stabilize the hormones. We also look to see whether or not they have been exercising regularly. If they are highly trained from a fitness perspective, then they are not eligible, so we do actually look for people who are relatively sedentary who are not participating in a structured exercise program already. We do that because we are trying to reach out to people who may be at a higher need for these interventions.

Do you care if a man has had surgery or radiation for prostate cancer?

Dr. Dieli-Conwright: No, we do not,  as long as the surgery or radiation is completed. If they’re actively on radiation or actively on chemotherapy we would wait until that treatment is done. Often we get calls from patients who are very enthusiastic and eligible, but then tell us they’re starting radiation next week. We have to wait until that treatment is over  and they’re cleared by their oncologist
for exercise.

Is there anything else you’d like patients to know either about this trial in particular or about exercise for cancer patients in general?

Dr. Dieli-Conwright: We’ve had a number of patients participate already. It’s been very successful. It’s safe. It’s feasible. Everybody’s enjoyed the program. We’ve had very high compliance to date— almost 100%. But it’s a strong time requirement —3 times a week for 16 weeks— so I would just say that if anybody is interested, even if it’s just a small amount, to contact us. We have very flexible scheduling times and can accommodate exercise almost 24/7. We have a large staff and a number of trainers who are eager to help. We try not to turn anybody away because of scheduling and try to work around work schedules if that’s a concern. We would love to take more patients.

For more information …
Contact Dr. Christina DieliConwright at 323-442-2905  or cdieli@pt.usc.edu

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