Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
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Purpose
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 |
|---|---|---|
|
Prostate Cancer |
Behavioral: behavioral dietary intervention Dietary Supplement: dietary intervention Procedure: therapeutic dietary intervention |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer |
| Enrollment: | 56 |
| Study Start Date: | July 2002 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: behavioral dietary intervention Dietary Supplement: dietary intervention Procedure: therapeutic dietary intervention |
|
No Intervention: Arm II: Observation
Observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.
|
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00082732
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00082732 History of Changes |
| Other Study ID Numbers: | CDR0000355833, MDA-DM-98054, DM98-054 |
| Study First Received: | May 14, 2004 |
| Last Updated: | October 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
stage I prostate cancer stage II prostate cancer adenocarcinoma of the prostate |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male Neoplasms |
Neoplasms by Site Prostatic Diseases Urogenital Neoplasms |
ClinicalTrials.gov processed this record on March 03, 2015