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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082732 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Procedure: behavioral dietary intervention Procedure: dietary intervention Procedure: therapeutic dietary intervention |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer |
Study Start Date: | July 2002 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this study.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
No histologically confirmed and/or demonstrable metastatic or locally recurrent disease by bone scan, chest x-ray, CT scan, or transrectal ultrasound
Documented biochemical failure after radical prostatectomy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Principal Investigator: | Richard J. Babaian, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000355833, MDA-DM-98054 |
Study First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00082732 |
Health Authority: | United States: Federal Government |
stage I prostate cancer stage II prostate cancer adenocarcinoma of the prostate |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site |