Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
NCT ID: NCT00082732
Last Updated: 2018-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2000-07-28
2006-02-27
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
behavioral dietary intervention
dietary intervention
therapeutic dietary intervention
Arm II: Observation
Observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.
No interventions assigned to this group
Interventions
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behavioral dietary intervention
dietary intervention
therapeutic dietary intervention
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Richard J. Babaian, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center official website
Other Identifiers
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MDA-DM-98054
Identifier Type: -
Identifier Source: secondary_id
DM98-054
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000355833
Identifier Type: -
Identifier Source: org_study_id
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