Soy Isoflavones and Breast Cancer Risk Reduction
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - 42 |
| Updated: | 3/17/2019 |
| Start Date: | April 2004 |
| End Date: | December 30, 2020 |
Mammographic Density and Soy Isoflavones
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.
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.
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.
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.
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
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