Soy Isoflavones and Breast Cancer Risk Reduction
This trial is active, not recruiting.
|Sponsor||The University of Texas Medical Branch, Galveston|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 2004|
|End date||December 2015|
|Trial size||187 participants|
|Trial identifier||NCT00204490, 03-260, 1UL1RR029876-01, M01RR000073, R01CA095545, UTMB GCRC #635|
Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
time frame: one or two years after dietary supplements
time frame: one or two years after dietary supplement
Female participants from 30 years up to 42 years old.
Inclusion Criteria: - healthy premenopausal women - 30 to 42 years old - normal mammograms - regular menstrual cycles Exclusion Criteria: - abnormal mammograms - first degree relatives with breast cancer - pregnant or lactating - peri- or post-menopause - breast augmentation, reduction or lifting - on oral contraceptive medications or exogenous hormones - medically prescribed diets - allergic reaction to soy products
|Official title||Mammographic Density and Soy Isoflavones|
|Principal investigator||Lee-Jane W Lu, Ph.D.|
|Description||This is a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.|
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