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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00513916
First received: August 8, 2007
Last updated: December 18, 2013
Last verified: April 2009
  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
Dietary Supplement: soy isoflavones
Phase 3

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

Resource links provided by NLM:


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
Study Completion Date: February 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii Cancer Research Center
Investigators
Study Chair: Gertraud Maskarinec, MD, PhD University of Hawaii Cancer Research Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gertraud Maskarinec, Cancer Research Center of Hawaii
ClinicalTrials.gov Identifier: NCT00513916     History of Changes
Other Study ID Numbers: CDR0000560821, UHM-CHS-4116
Study First Received: August 8, 2007
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer
healthy, no evidence of disease

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014