Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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), November 2008
Sponsors and Collaborators: Roswell Park Cancer Institute
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
Drug: flaxseed
Procedure: observation

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized
Official Title: A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk

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.
Drug: 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.

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:

      • Crohn disease
      • Ulcerative colitis
      • Irritable bowel syndrome
      • Celiac sprue
      • Malabsorption syndrome
      • Diverticulitis
      • Diverticulosis

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
    • 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 allergy to flaxseed, other seeds or nuts, wheat, lactose, or spices
    • No concurrent ingestion of the following:

      • Pumpkin seeds
      • Sesame seeds
      • Flaxseed supplements
      • Fish oil supplements
    • 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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Roswell Park Cancer Institute ( Swati Kulkarni )
Study ID Numbers: CDR0000617894, RPCI-I-81906
Study First Received: November 20, 2008
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00794989  
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

Study placed in the following topic categories:
Carcinoma, Lobular
Hyperplasia
Skin Diseases
Precancerous Conditions
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Breast Diseases
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009