Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
Status and phase
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Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- At least 3 weeks until planned prostatectomy (24 days between day 1 visit and surgery)
- Current diet that provides more than 30% of calories from fat
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Mentally competent
- Able to speak and write English
- Must have telephone access
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent hormonal therapy
Radiotherapy
- Not specified
Surgery
- At least 2 weeks since prior prostate biopsy
Other
- At least 7 days since prior antibiotics
- No prior therapy for prostate cancer
- No concurrent dietary supplements initiated within the past 3 months or anticipated to begin during study except standard multivitamin/mineral preparations (e.g., One-A-Day, Theragran, or Centrum) that do not supply > 100% of the recommended daily allowance of any vitamin or mineral
- No other concurrent neoadjuvant therapies
- No other concurrent flaxseed consumption
Trial design
Primary purpose
Allocation
Interventional model
Masking
161 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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