Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00082732
First received: May 14, 2004
Last updated: October 18, 2012
Last verified: October 2012
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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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
| 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| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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, 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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082732
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082732
Locations
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Richard J. Babaian, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| 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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Prostatic Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016