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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00513916
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Healthy, no Evidence of Disease Dietary Supplement: soy isoflavones Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Primary Purpose: Prevention
Official Title: Effects of Soy on Estrogens in Breast Fluid and Urine
Study Start Date : July 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum
  2. Cytologic patterns of epithelial breast cells obtained from NAF
  3. 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. Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513916


Locations
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United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Gertraud Maskarinec, MD, PhD University of Hawaii Cancer Research Center
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gertraud Maskarinec, Cancer Research Center of Hawaii
ClinicalTrials.gov Identifier: NCT00513916    
Other Study ID Numbers: CDR0000560821
UHM-CHS-4116
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: April 2009
Keywords provided by National Cancer Institute (NCI):
breast cancer
healthy, no evidence of disease
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases