flaxseed in preventing breast cancer in premenopausal women at risk of developing breast cancer

Conditions: Breast Cancer; Precancerous Condition

Summary: 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.

Eligibility criteria:
* patients enrolled in must meet ≥ 1 of the following criteria: * history of unilateral or bilateral atypical ductal hyperplasia with or without family history * history of atypical lobular hyperplasia or lobular carcinoma in situ with or without family history * history of ductal carcinoma in situ * prior stage i breast cancer allowed provided it was adequately treated and therapy was completed ≥ 1 year ago * lifetime risk for developing breast cancer \> 20% (based on gail or claus model) * no abnormal mammogram requiring short-term follow-up within the past 6 months * no severe atypia or carcinoma cells on rprna patient characteristics: * premenopausal * ecog performance status 0-1 * patients enrolled must meet the following criteria: * no peri- or postmenopausal status as determined by estradiol levels \ 45 ng/dl * no thrombocytopenia (defined as platelet count \< 50,000/mm\^3) * creatinine ≤ 1.5 mg/dl * not pregnant or nursing * fertile patients must use effective contraception consistently * no other prior malignancy allowed except for the following: * basal cell or squamous cell carcinoma * in situ cervical cancer * no history of any of the following conditions within the past 5 years: * crohn disease * ulcerative colitis * inflammatory bowel disease * irritable bowel syndrome * celiac sprue * malabsorption syndrome * diverticulitis * diverticulosis * no allergy to flaxseed, other seeds or nuts, or wheat prior concurrent therapy: * patients enrolled in part 1 must meet the following criteria: * no prior breast implants or tram-flap reconstruction * breast reduction allowed * no prior neoadjuvant chemotherapy or other chemotherapy within the past year * no prior neoadjuvant hormonal therapy * no prior whole radiation to the contralateral breast undergoing random periareolar fine needle aspiration (rpfna) * no concurrent coumadin or other chronic anticoagulants (even if they are held for surgery) * patients enrolled in part 2 must meet the following criteria: * more than 1 year since prior chemotherapy and adjuvant hormonal therapy for breast cancer * no concurrent chemotherapy for breast cancer * at least 1 month since prior and no concurrent treatment with corticosteroid * at least 2 weeks since prior and no concurrent use of antibiotics * at least 2 weeks * no history of chest wall irradiation * no presence of breast implants * no prior or concurrent tamoxifen within the past 90 days * no chronic/concurrent medications that inhibit platelet function, including any of the following: * aspirin * non-steroidal anti-inflammatory drugs (i.e., aleve®, motrin®, ibuprofen) * coumadin * heparin * low molecular weight heparin * anti-platelet agents * no prior short-term use of platelet inhibitors ≥ 7 days prior to rpfna * no concurrent ingestion of the following: * pumpkin seeds * sesame seeds * fish oil supplements * at least 30 days since prior and no concurrent flaxseed supplements, fish oil, or flaxseed oil * no concurrent treatment for another malignancy

Keywords: breast cancer atypical ductal breast hyperplasia lobular breast carcinoma in situ ductal breast carcinoma in situ breast cancer prevention high risk breast cancer