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Status:

TERMINATED

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

Lead Sponsor:

Roswell Park Cancer Institute

Conditions:

Breast Cancer

Precancerous Condition

Eligibility:

FEMALE

21-50 years

Phase:

NA

Brief 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 flaxsee...

Detailed Description

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 regul...

Eligibility Criteria

Inclusion

  • 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

    Key Trial Info

    Start Date :

    April 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2011

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT00794989

    Start Date

    April 1 2008

    End Date

    June 1 2011

    Last Update

    June 3 2016

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Chicago Medicine

    Chicago, Illinois, United States, 60637

    2

    Roswell Cancer Park Institute

    Buffalo, New York, United States, 14263