A research team in Belfast, Northern Ireland, has initiated a randomized, controlled clinical trial to assess the impact of diet and exercise on body composition, fatigue, and quality of life for patients who have are about to start androgen deprivation therapy (ADT).
Haseen et al. have described the structure of this study in the August issue of Trials.
To be eligible for the study, men must be scheduled to receive ADT for at least 6 months. Men randomized to the intervention arm will receive a home-based, tailored intervention with a series of very specific dietary guidelines. They will also be encouraged to take at least 30 minutes of brisk exercise (walking) on 5 or more days per week. Men randomized to the non-intervention arm will receive no specific guidance or intervention.
Primary outcomes are change in body composition, fatigue and quality of life scores. Secondary outcomes include dietary intake, physical activity and perceived stress.
Baseline data to be collected will include socioeconomic status, treatment duration, perceived social support and health status, family history of cancer, comorbidities, medication and supplement use, barriers to change, and readiness to change their health behavior. Data for the primary and secondary outcomes will be collected at baseline and at 3 and 6 months. A total of 94 patients will be enrolled in the study, with 47 randomized to each arm.
This trial out to be able to expand our appreciation of how a highly structured diet and exercise program can impact quality of life for men on ADT.
Filed under: Management, Treatment Tagged: | ADT, androgen deprivation, diet, exercise
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This is a potentially valuable study to document what are believed to be important roles for both diet/nutrition and exercise in mitigating side effects of hormonal therapy. The experts in blockade whom I follow all are convinced diet/nutrition/supplements and exercise are important based on their clinical experience. I believe they have served me well through 10.5 years of intermittent ADT (Lupron, Casodex, finasteride, plus Fosamax or Boniva for bone support, occasional thalidomide) as sole therapy. My three cycles on full therapy have lasted 34 months, 19 months, and 19 months.
However, I’m concerned about some aspects of the design. First, it is possible with a relatively small number of men in each arm (47) that bad luck will result in a disproportionately high number of men being assigned to one arm or the other who already are in good physical shape due to regular exercise and good dietary habits. That could skew results, and it is not being assessed or tracked per the abstract. I would suggest ruling out such fit individuals as part of the eligibility rules. (I would have been seen as fit and following fairly good nutritional practices when I was diagnosed, weeks before starting ADT; at least one of the doctors I saw made a special comment on that in his notes.)
I’m also concerned with compliance for men who go from a likely fairly sedentary lifestyle (maybe not so in Ireland) and less than desirable fiber intake to regular walking and a fairly high-fiber diet. Unless these men are counseled, they may balk when they realize they are producing a lot more gas and much looser stools as they go through the transition. That will “pass”, but it would help if they are counseled about what to expect and how to counter it. I have talked with a noted researcher about similar research who did not appreciate this issue before our conversation, and I’m betting that’s typical.
As for the walking, there too guidance would help enhance compliance. The increase needs to be gradual, and they should be advised how to pay attention to soreness and a heavy legs feeling so they can avoid injury. Very brisk walking can cause a number of problems if technique is poor, especially in the calf muscles and upper back. It does not appear that such support is planned.
Additionally, as important as the planned aerobic exercise (brisk walking) is, the experts I follow put heavy emphasis on strength exercise as part of the program, but strength exercise is not a part of the study. I’m personally a big believer in strength exercise as part of the program. It was not part of my program during my first 31 months of blockade, but I learned about it afterward (mainly via Dr. Mark Scholz and Dr. Charles “Snuffy” Myers). I have been able to maintain and even slightly build muscle strength through two 19 month long blockade intervals. (Many non-expert doctors treating prostate cancer will say that’s impossible with a negligibil testosterone level, but that’s not so. My T level was less than 10 during this last cycle that ended in April.) Fatigue and low-mood have never been a problem for me, and I credit stength exercise for some of that success. While it is likely too late to include a strength exercise aspect, the study still has a good shot at documenting the importance of diet and aerobic exercise.
I would also like to see a cardiovascular and diabetes workup added to the study and assessed as secondary endpoints. These additions would be neither hard nor expensive, but they are an important part of the ADT side effect profile. The intervention should document improvement or at least less deterioration per advice from leading ADT experts and my own experience.
It would be nice to see some intervention evidence of the degree of compliance with the intervention advice as another end point, but perhaps the body composition and other evidence to be collected will serve as a surrogate for that.
I’ll try to relay these thoughts to the lead researcher.
Thanks again for pointing out this important work.
Dear Jim: I suggest you ask for a copy of the actual article from the authors before criticizing their protocol. They may have thought of all of this. And my suspicion is that the study size is based on the funding available (as is the case for almost all clinical trials.)