Calorie restriction as a treatment for progressive prostate cancer: a real clinical trial


For the first time ever — as far as anyone seems to be aware — a major cancer center will soon start to implement a controlled, randomized clinical trial of calorie restriction as a treatment for cancer. And they will be doing this trial in men with progressive prostate cancer.

According to the trial information on the ClinicalTrials.gov web site, the clinical research team at Duke University intend to implement a pilot-scale, Phase II study in which a total of 60 men with a rising PSA after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (< 20 g carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome of the trial will be PSA doubling time.

A detailed discussion of the background to calorie restriction as a form of treatment for cancer is given in an article (“Calorie restriction to treat cancer: the time is n0w“) on the Medscape Oncology web site. Over the years we have accumulated significant data on this topic from animal studies and from clinical series of patients, but there has never before been an actual, randomized, controlled clinical trial.

The “New” Prostate Cancer InfoLink would strongly encourage eligible patients to enroll in this trial — particularly those who live in the Raleigh-Durham area of North Carolina. The key eligibility criteria are listed in the trial information link given above. We see this study as a key trial that could significantly impact future thinking about the management of progressive prostate cancer.

8 Responses

  1. Who to contact if interested?

  2. WHAT ABOUT CALORIES FROM PROTEIN, FATS?

    This trial is interesting, but will there be any control so that decreases in calories from carbs will not be negated by increases in calories from protein and fats? This strikes me as an important issue if you are trying to assess the impact of CALORIE restriction.

  3. Paul:

    There is no formal contact listed on the ClinicalTrials.gov web site as yet, but you could try sending an e-mail to Dr. Stephen Freedland (SFreedland@duke.edu).

  4. Dear Jim:

    I would be surprised if the investigators aren’t aware of this, and I would assume that this would be sddressed in the precise dietary guidelines for the patients randomized to the restricted diets.

  5. It will interesting to see the suggested menu for the low carb diet chosen. Monteil Williams says that his multiple sclerosis symptoms and inflammation have been reduced by 40% thanks to his diet rich in vegetables and fruit.

  6. Thank you.

  7. Am I missing something? The ClinicalTrials.gov web site only mentions carbohydrate restriction, not calorie restriction. Also, 20 g of carbohydrate is incredibly low. Twenty grams is less than an ounce and is only about 80 calories, i.e., 4% of a 2,000 cal diet. No whole food other than meat or dairy would have that kind of carbohydrate ratio, so what are these people going to eat so they don’t get serious vitamin deficiencies? There must be an error here as it doesn’t make sense. Perhaps they mean 20% of calories from carbohydrate?

  8. This is the problem with this type of summary of detailed clinical trial protocols. There is certainly “missing” information. I think we can reasonably assume that highly trained physicians at any major academic center understand that “man cannot live” on 80 calories of food intake a day (or for that matter on “bread alone”). Without seeing the full details of the proposed diet for those who are to have a carbohydrate-restricted diet, one cannot make any reasonable decision about what is being proposed here.

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