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A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk

21 Years
50 Years
Open (Enrolling)
Breast Cancer, Precancerous Condition

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Trial Information

A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk


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

- and evaluate the feasibility and tolerability of flaxseed consumption, and
determine factors that lead to decreased compliance


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.

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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Swati Kulkarni, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

February 2014

Related Keywords:

  • Breast Cancer
  • Precancerous Condition
  • breast cancer
  • atypical ductal breast hyperplasia
  • lobular breast carcinoma in situ
  • ductal breast carcinoma in situ
  • breast cancer prevention
  • high risk breast cancer
  • Breast Neoplasms
  • Precancerous Conditions



University of Chicago MedicineChicago, Illinois  60637
Roswell Cancer Park InstituteBuffalo, New York  14263