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

This study has been completed.
Sponsor:
Collaborator:
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
  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

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

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
Investigators
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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 29, 2014