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Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer Clinical research trials and Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer. Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer  Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 1 prostate cancer,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: A low-fat, high-fiber diet that includes soy protein may prevent disease progression in patients with hormone-refractoryprostate cancer. Nutrition counseling may help motivate patients to follow this diet. PURPOSE: Randomizedphase 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardBabaian, Principal Investigator, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Richard Babaian 713-792-3250
Additional Information:
Study ID Numbers: CDR0000355833; MDA-DM-98054
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082732
Other Adenocarcinoma Of The Prostate Studies:
1. Radiation Therapy in Treating Patients With Prostate Cancer
2. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
3. Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
4. Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer
5. Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
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