Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Hawaii Cancer Research Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00513916
First received: August 8, 2007
Last updated: April 30, 2009
Last verified: April 2009
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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 |
| Estimated 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:
No publications provided by National Cancer Institute (NCI)
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: | April 30, 2009 |
| 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 May 23, 2013