RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk of developing primary breast cancer. PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing breast cancer in premenopausal women at risk of breast cancer.
OBJECTIVES: Primary aims: * Determine if 25 grams of flaxseed supplementation daily * modifies proliferation (ki-67) and apoptotic rates after six months * modifies expression of estrogen regulated genes: Cyclin D1, survivin, and VEGF at six months * modifies serum IGF-1 and serum binding protein (IGFBP)-3 levels from baseline to 6 months * and evaluate the feasibility and tolerability of flaxseed consumption, and determine factors that lead to decreased compliance STUDY OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms. * Arm I (intervention): Patients ingest 25 grams ground flaxseed daily, with already prepared foods, for 6 months. Patients are instructed to record the time and with what foods flaxseed is consumed, and the number of bowel movements daily. Throughout the 6-month intervention period, patients also complete unannounced telephone-administered surveys recounting all foods and beverages consumed within the previous 24 hours. * Arm II (observation): Patients do not receive ground flaxseed. All patients complete a diary about menstrual cycle duration and presence or improvement of premenstrual symptoms (e.g., cramping, bloating, headache, insomnia, or other irregular symptoms). Patients also complete questionnaires at 1, 3, and 6 months to access changes in diet, physical activity, menstrual history, demographic characteristics, and medical history and a specimen questionnaire at baseline and at 1, 3, and 6 months. Blood and first-void urine samples are collected at baseline and at 1, 3, and 6 months to measure levels of lignan metabolites, flaxseed compliance, serum thiocyanate, malondialdehyde, and for biomarker studies by capillary gas chromatography-mass spectrometry, high-performance liquid chromatography, and ELISA. After completion of study therapy, patients are followed monthly for up to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Given orally
Participants randomized to Arm 2 do not receive any intervention
University of Chicago Medicine
Chicago, Illinois, United States
Roswell Cancer Park Institute
Buffalo, New York, United States
Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months
Time frame: 6 months
Tolerability and compliance
Time frame: 6 months
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