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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00794989
First received: November 20, 2008
Last updated: August 6, 2014
Last verified: August 2014
  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 Roswell Park Cancer Institute:

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: September 2014
Primary Completion Date: June 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794989

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

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00794989     History of Changes
Other Study ID Numbers: I 81906, RPCI-I-81906, 11-0575
Study First Received: November 20, 2008
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Roswell Park Cancer Institute:
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014