Sponsored by Roswell Park Cancer Institute

Phase	Quota	Distance
Phase N/A		Near

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

Interventions

• 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

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

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