CompletedPhase 2

Soy Isoflavones and Breast Cancer Risk Reduction

United States197 participantsStarted 2004-04

Plain-language summary

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.

Who can participate

Age range30 Years – 42 Years

SexFEMALE

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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

What they're measuring

Fibroglandular Tissue in Total Breast (FGBT%)

Timeframe: baseline, and after year 1 and 2 of supplementation

Breast Density by Mammography

Timeframe: baseline, and after year 1 and 2 of supplementation

Trial details

NCT IDNCT00204490

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12-10

Results submitted2023-12-05

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