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Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2009
First Received: November 20, 2008   Last Updated: September 10, 2009   History of Changes
Sponsor: Roswell Park Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00794989
  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/Nonmalignant Condition
Dietary Supplement: flaxseed
Procedure: observation

Study Type: Interventional
Study Design: Prevention, Randomized
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 National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • Long-term tolerability and compliance [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention: Experimental
Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.
Dietary Supplement: flaxseed
Given orally
Non-intervention: No Intervention
Patients do not receive ground flaxseed.
Procedure: observation
None

Detailed Description:

OBJECTIVES:

Primary

  • Develop consistent methods for collecting samples obtained by random periareolar fine needle aspiration (RPFNA) and transporting them to pathology for cytologic preparation [Part 1].
  • Develop consistent methods for optimizing cellular yield of RPFNA samples and performing immunohistochemistry on RPFNA samples [Part 1].
  • Develop consistent methods for performing qRT-PCR on RPFNA samples [Part 1].
  • Determine if consumption of ground flaxseed for 6 months in premenopausal women at increased risk will prevent the development of primary breast cancer [Part 2].
  • Determine if ground flaxseed will modify proliferation of intermediate biomarkers (Ki-67) and apoptotic rates (activated caspase-3) from baseline to 6 months in breast epithelial cells collected by RPFNA.
  • Determine modified expression of estrogen-regulated genes: cyclin D1, survivin, and VEGF in breast epithelial cells collected by RPFNA from baseline to 6 months [Part 2].
  • Determine if serum IGF-1 and serum binding protein (IGFBP)-3 levels are modified from baseline to 6 months [Part 2].

Secondary

  • Prepare for upcoming flaxseed chemoprevention study [Part 1].
  • Prepare for participation in future investigator-initiated chemopreventive trials involving RPFNA [Part 1].
  • Evaluate the feasibility and tolerance of long-term flaxseed consumption, and determine factors that lead to decreased compliance [Part 2].

OUTLINE: This is an open-label study (part 1) followed by a randomized study (part 2).

  • Part 1:

    • Patients undergo random periareolar fine needle aspiration (RPFNA) of the contralateral breast. Tissue samples are collected for cytology (morphology and nuclear atypia) analysis, immunohistochemistry for Ki-67 and caspase-3, and for estrogen-response genes by qRT-PCR.
  • Part 2:

Patients are randomized to 1 of 2 arms.

  • Arm I (intervention): Patients ingest 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

DISEASE CHARACTERISTICS:

  • Patients enrolled in part 1 must meet the following criteria:

    • Unilateral breast tumor (benign or malignant) scheduled for bilateral prophylactic mastectomy or unilateral prophylactic mastectomy at the Roswell Park Cancer Institute (RPCl) Breast Center
    • No contralateral breast malignancy by mammogram, ultrasound, and MRI

      • No finding that is suspicious and requires additional work-up (BIRADS class III-IV)
    • No metastatic malignancy of any kind
    • No low mammographic breast density (fatty breast or scattered fibroglandular elements)
  • Patients enrolled in part 2 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
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Premenopausal
  • ECOG performance status 0-1
  • Patients enrolled in part 1 must meet the following criteria:

    • Willing to provide demographic information, family history, and provide informed consent
    • Must know the start date of last menstrual cycle (if applicable)
    • At least 1 year since pregnancy or lactation
    • No postmenopausal status (defined as having no menstrual periods in the past year or surgical removal of both ovaries)
    • No type I or II diabetes
    • No body mass index > 30
  • Patients enrolled in part 2 must meet the following criteria:

    • No peri- or postmenopausal status as determined by estradiol levels < 20 ng/dL and FSH levels > 45 ng/dL
    • Not a current smoker (defined as having smoked any cigarettes within the last year)
    • 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

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Swati Kulkarni, MD     716-845-2918        
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Swati Kulkarni, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute ( Swati Kulkarni )
Study ID Numbers: CDR0000617894, RPCI-I-81906
Study First Received: November 20, 2008
Last Updated: September 10, 2009
ClinicalTrials.gov Identifier: NCT00794989     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer
atypical ductal breast hyperplasia
lobular breast carcinoma in situ
ductal breast carcinoma in situ
breast cancer

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

ClinicalTrials.gov processed this record on November 27, 2009