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

Roswell Park Comprehensive Cancer Center

Status

Terminated

Conditions

Breast Cancer

Precancerous Condition

Treatments

Other: No Intervention

Dietary Supplement: Ground Flaxseed

Study type

Interventional

Funder types

Other

Identifiers

NCT00794989

RPCI-I-81906 (Other Identifier)

I 81906

11-0575 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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