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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of the Effects of Dietary Soy on Estrogens in Breast Fluid, Serum, and Urine Samples From Healthy Women

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Biomarker/Laboratory analysis, Prevention Active 30 to 45 NCI UHM-CHS-4116 CHS 14116, NCT00513916

Trial Description

Purpose:

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.

This randomized phase III trial is studying the effects of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women.

Eligibility:

Eligibility criteria include the following:

• 30-45 years old
• No diagnosis of cancer
• Premenopausal and has regular menstrual cycles
• Not taking birth control pills or other hormones
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will be randomly assigned (have an equal chance of being placed) to one of two groups.

Participants in group one will eat two servings of soy foods a day for 6 months. Beginning 1 month later, they will eat fewer than three servings of soy foods a week for 6 months and will receive general nutrition counseling.

Participants in group two will eat fewer than three servings of soy foods a week for 6 months. They will also receive general nutrition counseling. Beginning 1 month later, participants will eat two servings of soy foods a day for 6 months.

Participants will undergo nipple fluid, urine, and blood sample collection periodically for laboratory studies.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Cancer Research Center of Hawaii

Gertraud Maskarinec, MD, PhD, Protocol chair		Ph: 808-586-3078 Email: gertraud@crch.hawaii.edu

U.S.A.
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		Clinical Trials Office - Cancer Research Center of Hawaii	Ph:  808-586-2979

Registry Information
Official Title		Effects of Soy on Estrogens in Breast Fluid and Urine
Trial Start Date		2006-07-01
Trial Completion Date		2011-02-28 (estimated)
Registered in ClinicalTrials.gov		NCT00513916
Date Submitted to PDQ		2007-07-27
Information Last Verified		2009-01-08
NCI Grant/Contract Number		CA080843