Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, 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

Objectives

1. Examine the effects of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum.
2. Investigate cytologic patterns of epithelial breast cells obtained from NAF as a measure of proliferation in relation to soy intake.
3. 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.
4. Compare estrogen levels in NAF and serum measured at the same time during the luteal phase.

Entry Criteria

Disease Characteristics:

• Healthy participant
  • No diagnosis of cancer

Prior/Concurrent Therapy:

• Not taking birth control pills or other hormones

Patient Characteristics:

• Premenopausal
• Regular menstrual cycles

Expected Enrollment

Outcomes

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

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.

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		2007-09-16
NCI Grant/Contract Number		CA080843