Status:
COMPLETED
Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 ene...
Eligibility Criteria
Inclusion
- 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, computed tomography (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
Exclusion
Key Trial Info
Start Date :
July 28 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2006
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00082732
Start Date
July 28 2000
End Date
February 27 2006
Last Update
November 6 2018
Active Locations (1)
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1
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009