Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women

Breast Cancer, Healthy, no Evidence of Disease

breast cancer, healthy, no evidence of disease

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a diet high in isoflavones, compounds found in soy foods, may keep cancer from forming. PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women.

OBJECTIVES: * Examine the effects of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum. * Investigate cytologic patterns of epithelial breast cells obtained from NAF as a measure of proliferation in relation to soy intake. * Explore the effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen metabolites. * Compare estrogen levels in NAF and serum measured at the same time during the luteal phase. OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 intervention arms. * Arm I: Participants partake in a high soy diet consisting of 2 daily soy servings (approximately 50mg isoflavones). The choice of soy foods will include ½ cup of tofu, ¾ cup of soy milk, or ¼ cup of soy nuts. Replacement of currently consumed foods with soy foods will be encouraged. * Arm II: Participants will be asked to keep their soy intake below 3 servings per week. The participants will also receive general nutrition counseling. In both arms, intervention continues for 6 months. After 6 months, participants undergo a 1-month washout period and then cross-over to the other intervention arm. Nipple aspirate fluid, urine, and blood samples are collected periodically to measure laboratory endpoints.

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