Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Houston, Texas 77030


Purpose:

RATIONALE: A low-fat, high-fiber diet that includes soy protein may prevent disease progression in patients with hormone-refractory prostate cancer. Nutrition counseling may help motivate patients to follow this diet. PURPOSE: Randomized phase I trial to study the effectiveness of behavior-based dietary interventions, such as receiving nutrition counseling, in helping patients who have hormone-refractory prostate cancer follow a low-fat, high-fiber, soy-supplemented diet.


Study summary:

OBJECTIVES: - 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 study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - No small cell component - No histologically confirmed and/or demonstrable metastatic or locally recurrent disease by bone scan, chest x-ray, CT scan, or transrectal ultrasound - No clinical symptoms within the past 90 days - Documented biochemical failure after radical prostatectomy - Prostate-specific antigen must have initially nadired to an undetectable level (< 0.1 ng/mL) after prostatectomy AND is currently rising (0.3-40.0 ng/mL) - Serum testosterone > 100 ng/dL PATIENT CHARACTERISTICS: Age - Any age Performance status - Zubrod 0-1 Life expectancy - At least 1 year Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - No known allergic reactions to milk or soy products PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 1 year since prior chemotherapy Endocrine therapy - More than 1 year since prior hormonal therapy Radiotherapy - Not specified Surgery - See Disease Characteristics


NCT ID:

NCT00082732


Primary Contact:

Principal Investigator
Richard J. Babaian, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.