Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/8/2018 |
| Start Date: | July 28, 2000 |
| End Date: | February 27, 2006 |
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.
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.
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.
- 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.
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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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