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

This study is no longer recruiting patients.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


RATIONALE: A low-fat, high-fiber diet that includes soy protein may prevent disease progression in patients with hormone-refractoryprostate cancer. Nutrition counseling may help motivate patients to follow this diet.

PURPOSE: Randomizedphase 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 Treatment or Intervention Phase
stage I prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: dietary intervention
Phase I

MedlinePlus related topics:  Prostate Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Randomized Pilot Study of Behavior-Based Dietary Intervention in Patients With Hormone-Refractory Prostate Cancer

Further Study Details: 


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.


Genders Eligible for Study:  Both



  • 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, 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


  • Any age

Performance status

  • Zubrod 0-1

Life expectancy

  • At least 1 year


  • Not specified


  • Not specified


  • Not specified


  • No known allergic reactions to milk or soy products


  • Not specified


  • More than 1 year since prior chemotherapy

Endocrine therapy

  • More than 1 year since prior hormonal therapy


  • Not specified


  • See Disease Characteristics

Location Information

      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Richard J. Babaian, MD,  Principal Investigator,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000355833; MDA-DM-98054
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  May 14, 2004 Identifier:  NCT00082732
Health Authority: Unspecified processed this record on 2005-04-08

Cache Date: April 9, 2005