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

Sponsored by Roswell Park Cancer Institute

Phase Quota
Phase N/A

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.

Study Start Date: April 2008

Estimated Completion Date: June 2011

Specialties: Internal Medicine: Complementary Medicine,Hematology/Oncology,Preventive Medicine,Women`s Health Obstetrics & Gynecology: Breast,Complementary Medicine,Gynecologic Oncology,Preventive Medicine Family Medicine: Complementary Medicine,Preventive/Nutrition,Women`s Health Oncology: Breast Pharmacy: Complementary Medicine


  • Other: questionnaire administration
  • Other: No Intervention
  • Dietary Supplement: flaxseed
  • Dietary Supplement: Ground Flaxseed

Inclusion 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


  • 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


  • 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

Exclusion criteria

Study Locations And Contact Information

  • University of Chicago Medicine, Chicago Illinois
  • Roswell Cancer Park Institute, Buffalo New York
  • University of Chicago Medicine, Chicago Illinois
  • Roswell Cancer Park Institute, Buffalo New York

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