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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Soy on Estrogens in Breast Fluid and Urine

Conditions
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Breast Cancer, Healthy, no Evidence of Disease

Intervention / Treatment
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* Dietary Supplement: soy isoflavones


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Healthy participant No diagnosis of cancer PATIENT CHARACTERISTICS: Premenopausal Regular menstrual cycles PRIOR CONCURRENT THERAPY: Not taking birth control pills or other hormones

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Dietary Supplement: soy isoflavones<br>* High or low dose of soy isoflavones in the diet.<br>|
| Active Comparator: Arm II<br>Participants will be asked to keep their soy intake below 3 servings per week. The participants will also receive general nutrition counseling. | Dietary Supplement: soy isoflavones<br>* High or low dose of soy isoflavones in the diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum |  |  | 
| Cytologic patterns of epithelial breast cells obtained from NAF |  |  | 
| 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 |  |  | 
| Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, healthy, no evidence of disease