A Phase 2 interventional study of dietary intervention and flaxseed in Prostate Cancer, sponsored by Duke University. Completed at 3 sites in United States. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 161 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Usual diet
30 gram flaxseed dietary modification
Dietary Supplement: flaxseed
Low fat dietary modification
Dietary Supplement: dietary intervention
Low fat and 30 gram flaxseed dietary modification
Dietary Supplement: dietary intervention · Dietary Supplement: flaxseed
Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy
Prostatic Carcinoma Apoptotic Index by TUNEL assay at time of prostatectomy
Prostate-specific antigen by Hybritech assay at baseline and follow-up
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
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Duke University