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

Breast Cancer Clinical Trial

Official title:

Effects of Soy on Estrogens in Breast Fluid and Urine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513916
• Other study ID #: CDR0000560821
• Secondary ID: UHM-CHS-4116
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2007
• Last updated: December 18, 2013
• Start date: July 2006
• Est. completion date: February 2012

Study information

• Verified date: April 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Healthy, no Evidence of Disease

Intervention

Dietary Supplement:
• soy isoflavones
High or low dose of soy isoflavones in the diet.

Locations

Country	Name	City	State
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Maskarinec G, Morimoto Y, Conroy SM, Pagano IS, Franke AA. The volume of nipple aspirate fluid is not affected by 6 months of treatment with soy foods in premenopausal women. J Nutr. 2011 Apr 1;141(4):626-30. doi: 10.3945/jn.110.133769. Epub 2011 Feb 16. — View Citation

Sen C, Morimoto Y, Heak S, Cooney RV, Franke AA, Maskarinec G. Soy foods and urinary isoprostanes: results from a randomized study in premenopausal women. Food Funct. 2012 May;3(5):517-21. doi: 10.1039/c2fo10251j. Epub 2012 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum			No
Primary	Cytologic patterns of epithelial breast cells obtained from NAF			No
Primary	Effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16a-, and 4-hydroxy estrogen metabolites			No
Primary	Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase			No