Flaxseed is a natural food source containing lignan, a phytoestrogen, and alpha-linolenic acid, an omega-3 fatty acid. Flaxseed consumption has been reported in preclinical and clinical studies to decrease tumor growth through anti-estrogenic activity and estrogen-independent mechanisms in both estrogen receptor (ER) positive and ER negative breast cancers, and flaxseed has no known serious side effects. A pilot study is proposed to test the central hypothesis that flaxseed will be a safe and effective chemopreventive agent in healthy premenopausal women at high risk of breast cancer. The central hypothesis will be tested with the following specific aims: determine if the daily consumption of 25 grams of ground flaxseed 1) alters the proportion of breast epithelial cells expressing Ki-67 and caspase-3 (a measure of apoptosis) after six months in random periareolar fine needle aspiration (RPFNA) samples; 2)alters estrogen regulated genes, cyclin D1, survivin and vascular endothelial growth factor (VEGF) in RPFNA samples; 3) alters serum levels of IGF-1 and IGFBP-3 after six months and 4) produces any significant side effects in premenopausal women who are at increased risk of developing of breast cancer based on elevated Gail and Claus scores, history of atypia on surgical biopsy,or history of unilateral breast cancer, and Ki-67 labeling index >1.5% on random periareolar fine needle aspiration samples (RPFNA).
This study at University of Chicago is exploring the effect that flaxseed has on biological markers (biomarkers) associated with breast cancer risk in the breast cells of women who have had ADH, ALH, LCIS, or DCIS and are not taking tamoxifen. The researchers needed to enroll up to 30 volunteers. They contacted the Army of Women (AOW) to help them complete recruitment. The Call to Action for this study was sent to AOW members on Feb. 12, 2014, and the researchers closed enrollment on July 15, 2014. The AOW provided them with seven women who were interested in enrolling in the study.