Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Procedure: therapeutic dietary intervention; Behavioral: behavioral dietary intervention; Dietary Supplement: dietary intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00082732

DM98-054 (Other Identifier)

CDR0000355833

MDA-DM-98054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Arm I: Dietary Intervention

Experimental group

Description:

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:

Behavioral: behavioral dietary intervention

Procedure: therapeutic dietary intervention

Dietary Supplement: dietary intervention

Arm II: Observation

No Intervention group

Description:

Observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.