Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
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.
Dietary Supplement: dietary intervention
Dietary Supplement: flaxseed
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets|
- Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy [ Designated as safety issue: No ]
- Prostatic Carcinoma Apoptotic Index by TUNEL assay at time of prostatectomy [ Designated as safety issue: No ]
- Prostate-specific antigen by Hybritech assay at baseline and follow-up [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
|Study Start Date:||January 2003|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
No Intervention: Control
Experimental: Flaxseed diet
30 gram flaxseed dietary modification
|Dietary Supplement: flaxseed|
Experimental: Low fat diet
Low fat dietary modification
|Dietary Supplement: dietary intervention|
Experimental: Low fat + Flaxseed diet
Low fat and 30 gram flaxseed dietary modification
|Dietary Supplement: dietary intervention Dietary Supplement: flaxseed|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049309
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Wendy Demark-Wahnefried, PhD||Duke Cancer Institute|