Breast Cancer Clinical Trial

Soy Protein and Breast Cancer Risk Reduction

Summary

Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.

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Full Description

The aims will be tested by conducting 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 two different dietary supplements daily for 2 years. The two test diets soy protein drink and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary intervention period and analyzed for ovarian hormones. At baseline and after the intervention period, breast density, and bone density will be assessed by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids, and density of the breast and bone tissues over the 2 year dietary intervention period in the two diet groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soya dietary supplements will reduce breast density, which will be explained by individual hormonal changes.

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Eligibility Criteria

Inclusion Criteria:

healthy premenopausal women
30 to 40 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, and lifting
on oral contraceptive medications or exogenous hormones
medically prescribed diets
allergic reaction to soy or cow's milk

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

313

Study ID:

NCT00204477

Recruitment Status:

Active, not recruiting

Sponsor:

The University of Texas Medical Branch, Galveston

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There is 1 Location for this study

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General Clinical Research Center, The University of Texas Medical Branch
Galveston Texas, 77555, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

313

Study ID:

NCT00204477

Recruitment Status:

Active, not recruiting

Sponsor:


The University of Texas Medical Branch, Galveston

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