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

This study is currently recruiting participants.
Verified April 2013 by University of Chicago
Sponsor:
Collaborator:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00794989
First received: November 20, 2008
Last updated: September 4, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Precancerous Condition
Dietary Supplement: Ground Flaxseed
Other: No Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and compliance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Intervention
Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.
Dietary Supplement: Ground Flaxseed
Given orally
Arm 2: Observational
Patients do not receive ground flaxseed.
Other: No Intervention
Participants randomized to Arm 2 do not receive any intervention

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 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

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794989

Contacts
Contact: Kelsey Watson, B.S. 773-702-9113 kwatson1@surgery.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact    773-702-9113      
United States, New York
Roswell Cancer Park Institute Recruiting
Buffalo, New York, United States, 14263
Sponsors and Collaborators
University of Chicago
Roswell Park Cancer Institute
Investigators
Principal Investigator: Swati Kulkarni, M.D. University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00794989     History of Changes
Other Study ID Numbers: 11-0575, RPCI-I-81906, 11-0575
Study First Received: November 20, 2008
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
breast cancer
atypical ductal breast hyperplasia
lobular breast carcinoma in situ
ductal breast carcinoma in situ
breast cancer prevention
high risk breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Precancerous Conditions
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 23, 2014