Let’s prove the obvious all over again

Once again your sitemaster finds himself flabbergasted at just how often we need to repeat similar experiments to prove the obvious.

A newly published article in the Annals of Behavioral Medicine is entitled, “Effects of a group-mediated exercise and dietary intervention in the treatment of prostate cancer patients undergoing androgen deprivation therapy: results from the IDEA-P trial”. Here’s a link to the abstract.

The authors begin by stating that

Although androgen-deprivation therapy (ADT) is the foundation of treatment for prostate cancer, the physiological impacts of ADT result in functional decline and enhanced risk of chronic disease and metabolic syndrome.

Your sitemaster hopes that they understand that ADT is actually the foundation for the treatment of advanced and metastatic forms of prostate cancer.

So based on this revelation, they put together a randomized trial among 32 prostate cancer patients (of an average age of about 66 years) who were being treated with ADT:

  • 16 of the patients were randomized to a program involving “a group-mediated, cognitive-behavioral (GMCB) exercise and dietary intervention (EX+D)”, in other words an intensive, carefully supervised diet and exercise program, for a period of 12 weeks.
  • The other 16 patients were randomized to a standard-of-care (SC) control program, i.e., nothing, for the same 12 weeks.

To your sitemaster’s absolute astonishment, the research team was able to show that:

  • “Favorable adherence and retention rates were observed.”
  • There were “no serious intervention-related adverse events”.
  • The men in the EX+D arm of the trial exhibited “significantly greater improvements in mobility performance (p < 0.02), muscular strength (p < 0.01), body fat percentage (p < 0.05), and fat mass (p < 0.03) at 3-month follow-up, relative to control.”

And the authors somehow manged to come to the conclusion that

Findings from the IDEA-P trial suggest that a GMCB-based EX+D intervention resulted in significant, clinically meaningful improvements in mobility performance, muscular strength, and body composition, relative to controls. Collectively, these results suggest that the EX+D was a safe and well-tolerated intervention for prostate cancer patients on ADT. The utility of implementing this approach in the treatment of prostate cancer patients on ADT should be evaluated in future large-scale efficacy trials.

Your sitemaster has no idea who funded this study but clearly they hadn’t read any prostate cancer literature at all over the past 20+ years. So let me be very clear:

  • For men with prostate cancer who are on treatment with ADT, a healthy diet and regular exercise will almost invariably
    • Induce “clinically meaningful improvements in mobility performance, muscular strength, and body composition”
    • Improve patients’ quality of life in multiple ways
    • Have potential long-term benefits with regard to mental function
  • The chances that men will adapt their lifestyles to take advantage of this knowledge is increased when they are taught how to make such changes by suitably trained dietitians and personal trainers as soon as they start ADT.

We have known all this for most of the past 20 years — and researchers in Australia validated all of this years ago.

It’s high time we stopped wasting money on trials like this and put that money into making sure that services were being made available to men on ADT to ensure that they all have the opportunity to learn how to take advantage of this knowledge to improve their overall care and their quality of life. We don’t need “future large-scale efficacy trials” to prove this. We need to take practical steps to make it happen!

9 Responses

  1. Lovely summary Mike. The issue, as you say, is not proving that a good diet and exercise are helpful for patients on ADT. Rather the challenge is to get get men to make those life style changes.

  2. Well, I was told nothing and am paying for that now. My attempts to find out about fatigue were brushed off, as was a request for information about osteoporosis. I got the information at another division of that hospital. After two small errors I left oncology and switched to urology.

    I thought I had hypogonadism from low testosterone but now nobody knows for sure. About 1 month ago I read about the metabolic syndrome but the paper said that men’s symptoms seen to overlap with those of that syndrome. To check I contacted urology without any appointment and asked to speak with one of two fine urologists. I got one. We spoke for about 20 minutes. He confirmed the overlap idea and told me that the matter is under investigation right now. He advised me to contact a general practitioner (GP) as they can set up some kind of lifestyle intervention. We will see what happens. I see the GP on the 24th.

  3. The authors are all academics from Ohio State University, so I’m thinking the motivation for this trial falls under, “Publish or Perish.” And of course, by encouraging further investigations of this nature, they hope to get other desperate researchers to cite their paper. It’s the name of the game and the reason for countless other useless publications.

  4. Amen! After four rounds of IADT3, I am a total believer in the great value of exercise and diet. And yes, we have known that for a very long time. Like Sitemaster and Richard, I too see the challenge of getting patients to adopt the necessary lifestyle changes; it is abundantly clear that many of us are not taking these key steps.

    ADT will cause a number of burdensome side effects for most of us, but there are countermeasures that are at least somewhat effective for most of us for all of these side effects, and these too have been known for a long time, though that knowledge has not been widespread among doctors and patients. Going through ADT without employing the countermeasures is like going into battle without body armor.

  5. Dear Len:

    I understand the authors’ motivations. What I don’t understand is why the funders of this research were willing to waste their money on it.

  6. It’s worse. The only conclusion that can safely be drawn is that men on ADT are human beings (on whom it has been conclusively proved these effects of diet and exercise should be expected). And we knew that anyway.

  7. ADT Hormone therapy, big profits and devastating side effects: Lupron injections are a common and expensive treatment. Men are prescribed ADT hormone therapy, AKA chemical castration as an additional or only treatment. ADT therapy is sometimes over prescribed for profit, per some studies. Hormone therapy is often very expensive (Profitable for doctors if provided at the doctor’s office). It has horrible, strange and devastating side effects; feminization, hot flashes, fatigue, weight gain, metabolic syndrome, long term or permanent ED, depression, the penis could shrink and testicles can completely disappear, he may grow breasts. This treatment has numerous mind and body altering side effects. One man stated that ADT therapy turned him into an emotional, obese, menopausal woman. Men are sometimes actually castrated (orchiectomy) as a cancer treatment to reduce testosterone. Amnesty International calls chemical castration “inhuman”. Studies (Medicare and financial) have documented doctors do over prescribe ADT therapy for profit (depending on Insurance payout rates/profit margin). When insurance payment reimbursement for ADT decreased so did the number of patients being prescribed ADT therapy [17,18]. Per Wikipedia: “in patients with localized prostate cancer, confined to the prostate, ADT has demonstrated no survival advantage, and significant harm, such as impotence, diabetes and bone loss. Even so, 80% of American doctors provide ADT to patients with localized prostate cancer.” Overtreatment with ADT is extremely profitable, unfortunate and avoidable.

    17. Reimbursement Policy and Androgen-Deprivation Therapy for Prostate Cancer Vahakn B. Shahinian, M.D., Yong-Fang Kuo, Ph.D., and Scott M. Gilbert, M.D. N Engl J Med 2010; 363:1822-1832November 4, 2010
    18. Medicare Reimbursement and Prescribing Hormone Therapy for Prostate Cancer Nancy L. Keating. JNCI: Journal of the National Cancer Institute, Volume 102, Issue 24, 15 December 2010, Pages 1814–1815.

    Go to: http://www.yananow.org/display_story.php?id=1659 and read more

  8. As usual, JJ (who goes by a variety of names) can only see the downsides of anything to do with medical care. There are plenty of those, but if he had ever actually suffered from the pain associated with late stage, metastatic prostate cancer to the bones, he might be more willing to see the upsides too.

    And I would note that the Amnesty International’s comment about “chemical castration” is related to its use, for example, as a form of punishment for men convicted of sexual violence against children in aggravated circumstances. One might or might not agree with that comment (especially if one was an 8-year-old child who had been raped). It has nothing whatsoever to do with the use of ADT in the treatment of prostate cancer.

    JJ. I am willing to post some of your comments on your personal views about prostate cancer and its treatment, but you need to get your facts correct please.

  9. Newly diagnosed prostate cancer patient here. Hi all.

    Sorry to jump on an old post, but it is what I came across and I wanted to sign up. I certainly understand the frustration, but there was a valid scientific hypothesis tested here and the money wasn’t wasted. It was employed to design and test the Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) (they love acronyms don’t they)! It worked and it is notable that such approaches are not currently “standard-of-care (SoC). They cost money and health insurers won’t pay for them unless the FDA mandates them.

    The point of such studies is not to educate the patients, but the care teams and docs (and FDA). Medicine is still an art, not a science. It does not move linearly, but more like the Brownian motion (like movement of a motile bacterium along a food source gradient). Hopefully we will get to the right place eventually. Such detailed approaches that demonstrate a significant improvement in life repeatedly nudge the SoC toward their use.

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