Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer
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 Overview
Status
Conditions
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Texas
-
Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I: Dietary Intervention
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.
|
|
|
No Intervention: Arm II: Observation
Observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard J. Babaian, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000355833
- MDA-DM-98054
- DM98-054 (Other Identifier: UT MD Anderson Cancer Center)
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