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

Sponsors and Collaborators:	University of Hawaii Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00513916

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Healthy, no Evidence of Disease	Drug: soy isoflavones	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized
Official Title:	Effects of Soy on Estrogens in Breast Fluid and Urine

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum [ Designated as safety issue: No ]
Cytologic patterns of epithelial breast cells obtained from NAF [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2006
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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.	Drug: soy isoflavones High or low dose of soy isoflavones in the diet.
Arm II: Active Comparator Participants will be asked to keep their soy intake below 3 servings per week. The participants will also receive general nutrition counseling.	Drug: soy isoflavones High or low dose of soy isoflavones in the diet.

Detailed 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.

Eligibility

Ages Eligible for Study:	30 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513916

Locations

United States, Hawaii
Cancer Research Center of Hawaii	Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii 808-586-2979

Sponsors and Collaborators

University of Hawaii Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Gertraud Maskarinec, MD, PhD

University of Hawaii Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000560821, UHM-CHS-4116
Study First Received:	August 8, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00513916
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer
healthy, no evidence of disease

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Healthy
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009