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Clinical Trial: Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage I prostate cancer stage II prostate cancer adenocarcinoma of the prostate | Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: dietary intervention | Phase I |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Randomized Pilot Study of Behavior-Based Dietary Intervention in Patients With Hormone-Refractory Prostate Cancer
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
Genders Eligible for Study: Both
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
Location Information
Richard J. Babaian, MD, Principal Investigator, M.D. Anderson Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: May 14, 2004
ClinicalTrials.gov Identifier: NCT00082732
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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