Clinical trial NCT00513916: Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women
Official title: Effects of Soy on Estrogens in Breast Fluid and Urine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Healthy, no Evidence of Disease
Keywords: breast cancer
healthy, no evidence of disease
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum
measure: Cytologic patterns of epithelial breast cells obtained from NAF
measure: 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
measure: Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: Gertraud Maskarinec, MD, PhD
role: STUDY_CHAIR
References:
citation: Sen C, Morimoto Y, Heak S, Cooney RV, Franke AA, Maskarinec G. Soy foods and urinary isoprostanes: results from a randomized study in premenopausal women. Food Funct. 2012 May;3(5):517-21. doi: 10.1039/c2fo10251j. Epub 2012 Feb 14.
citation: Maskarinec G, Morimoto Y, Conroy SM, Pagano IS, Franke AA. The volume of nipple aspirate fluid is not affected by 6 months of treatment with soy foods in premenopausal women. J Nutr. 2011 Apr 1;141(4):626-30. doi: 10.3945/jn.110.133769. Epub 2011 Feb 16.
citation: Maskarinec G, Suzuki S, Pagano IS, Morimoto Y, Franke AA, Ehya H. Cytology in nipple aspirate fluid during a randomized soy food intervention among premenopausal women. Nutr Cancer. 2013;65(8):1116-21. doi: 10.1080/01635581.2013.833638. Epub 2013 Oct 15.