Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Dietary Supplement: dietary interventionDietary Supplement: flaxseed
- Registration Number
- NCT00049309
- Lead Sponsor
- Duke University
- Brief Summary
RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease progression of prostate cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of a diet that is low in fat and/or high in flaxseed in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.
- Detailed Description
OBJECTIVES:
* Compare tumor proliferation in patients with newly diagnosed prostate cancer eating fat- and/or flaxseed-modified diets.
* Compare differences in histopathological markers associated with prostate cancer (rates of apoptosis, extent of high-grade prostatic intraepithelial neoplasia) among patients in these diet groups.
* Compare changes in serum prostate specific antigen among patients in these diet groups.
* Compare changes in hormone-related factors (total serum testosterone and free androgen index, insulin-like growth factor \[IGF\], and IGF-binding protein-3) among patients in these diet groups.
* Compare the effects of diet on nutritional biomarkers (levels of lignans in the urine and ejaculate, fatty acid profiles of erythrocytes and prostatic tissue) in these patients.
* Determine associations between dietary modification and changes in dietary biomarkers, hormonal intermediates, and study endpoints in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to Gleason score (less than 7 vs at least 7) and race (black vs non-black). Patients are randomized to 1 of 4 diet groups.
* Arm I (Flaxseed-supplemented diet): Patients are instructed to incorporate ground flaxseed into their daily diets.
* Arm II (Low-fat diet): Patients are instructed on ways to achieve a diet with no greater than 20% of total energy from dietary fat.
* Arm III (Flaxseed-supplemented, low-fat diet): Patients are instructed as in arm I and arm II.
* Arm IV (Control diet): Patients are contacted weekly, but do not receive dietary counseling until after surgery.
All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery. After surgery, all patients receive dietary counseling.
PROJECTED ACCRUAL: A total of 160 patients (40 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 161
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low fat diet dietary intervention Low fat dietary modification Low fat + Flaxseed diet dietary intervention Low fat and 30 gram flaxseed dietary modification Flaxseed diet flaxseed 30 gram flaxseed dietary modification Low fat + Flaxseed diet flaxseed Low fat and 30 gram flaxseed dietary modification
- Primary Outcome Measures
Name Time Method Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy
- Secondary Outcome Measures
Name Time Method Prostatic Carcinoma Apoptotic Index by TUNEL assay at time of prostatectomy Total testosterone, sex hormone binding globulin, insulin-like growth factor (IGF), and IGF-binding protein-3, total cholesterol, and low-density lipoprotein cholesterol by ELISA assays at baseline and follow-up Prostate-specific antigen by Hybritech assay at baseline and follow-up
Trial Locations
- Locations (3)
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States