Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer
- Determine whether a behavior-based dietary intervention can motivate patients with
hormone-refractory prostate cancer to adopt and maintain a dietary pattern that
includes < 20% of energy from fat, > 25 g of fiber, and 80 g of soy protein powder.
- Compare bioavailable levels of testosterone in patients treated with a behavior-based
dietary intervention vs observation only.
- Determine whether this dietary intervention decreases or stabilizes a rising serum
prostate-specific antigen level in these patients.
- Determine whether this dietary intervention improves disease-specific survival,
mediated by reduced bioavailable levels of testosterone, in these patients.
- Determine the impact of a positive intervention outcome on androgen receptors in
patients treated with this dietary intervention.
OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are randomized
to 1 of 2 treatment arms.
All patients receive nutritional counseling on a healthy diet. Patients also keep a food
diary during study participation.
- Arm I (dietary intervention): Patients receive dietary intervention comprising
nutritional counseling on a low-fat, high-fiber, soy supplemented diet and
behavior-based activities, such as goal-setting, contracting, and stimulus control,
once weekly for 6 weeks, every 3 weeks for 33 weeks, and then at weeks 44, 48, and 52.
Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II (observation): Patients undergo observation every 6 weeks for 36 weeks and then
every 8 weeks for 18 weeks.
PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Richard J. Babaian, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|