Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk

Conditions
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Breast Cancer, Precancerous Condition

Intervention / Treatment
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* Dietary Supplement: Ground Flaxseed
* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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 < 20 ng/dL and FSH 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Intervention<br>Patients ingest ground flaxseed daily, with already prepared foods, for 6 months. | Dietary Supplement: Ground Flaxseed<br>* Given orally<br>|
| Other: Arm 2: Observational<br>Patients do not receive ground flaxseed. | Other: No Intervention<br>* Participants randomized to Arm 2 do not receive any intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and compliance |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, atypical ductal breast hyperplasia, lobular breast carcinoma in situ, ductal breast carcinoma in situ, breast cancer prevention, high risk breast cancer