A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk
- 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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months
Swati Kulkarni, M.D.
University of Chicago
United States: Institutional Review Board
|University of Chicago Medicine||Chicago, Illinois 60637|
|Roswell Cancer Park Institute||Buffalo, New York 14263|