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

December 18, 2013 updated by: University of Hawaii Cancer Research Center

Effects of Soy on Estrogens in Breast Fluid and Urine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: soy isoflavones
High or low dose of soy isoflavones in the diet.
Active Comparator: Arm II
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
High or low dose of soy isoflavones in the diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii Cancer Research Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Gertraud Maskarinec, MD, PhD, University of Hawaii Cancer Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 9, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000560821
  • UHM-CHS-4116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on soy isoflavones

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe