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

NCT ID: NCT00794989

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-06-30

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 flaxseed works in preventing breast cancer in premenopausal women at risk of breast cancer.

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.

Conditions

Breast Cancer; Precancerous Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1: Intervention

Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.

Group Type: EXPERIMENTAL

Ground Flaxseed

Intervention Type: DIETARY_SUPPLEMENT

Given orally

Arm 2: Observational

Patients do not receive ground flaxseed.

Group Type: OTHER

No Intervention

Intervention Type: OTHER

Participants randomized to Arm 2 do not receive any intervention

Interventions

Ground Flaxseed

Given orally

Intervention Type: DIETARY_SUPPLEMENT

No Intervention

Participants randomized to Arm 2 do not receive any intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Swati Kulkarni, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medicine

Chicago, Illinois, United States

Roswell Cancer Park Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-81906

Identifier Type: OTHER

Identifier Source: secondary_id

11-0575

Identifier Type: OTHER

Identifier Source: secondary_id

I 81906

Identifier Type: -

Identifier Source: org_study_id