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

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ClinicalTrials.gov Identifier: NCT00082732
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : October 22, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Behavioral: behavioral dietary intervention Dietary Supplement: dietary intervention Procedure: therapeutic dietary intervention Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer
Study Start Date : July 2002
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
MD Anderson Cancer Center official website  This link exits the ClinicalTrials.gov site

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00082732     History of Changes
Other Study ID Numbers: CDR0000355833
MDA-DM-98054
DM98-054 ( Other Identifier: UT MD Anderson Cancer Center )
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012

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