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

NCT00513916 | Completed Phase 3

• 2 other identifiers: CDR0000560821UHM-CHS-4116
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Healthy, no Evidence of Disease

Keywords

breast cancer; healthy, no evidence of disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

ACTIVE COMPARATOR

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

Interventions

soy isoflavones DIETARY_SUPPLEMENT

High or low dose of soy isoflavones in the diet.

Arm I; Arm II

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Hawaii Cancer Research Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Related Publications (3)

• 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.

  PMID: 22331037 RESULT

• 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.

  PMID: 21325473 RESULT

• 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.

  PMID: 24127645 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Gertraud Maskarinec, MD, PhD

  University of Hawaii Cancer Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: July 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 19, 2013

Record last verified: 2009-04

Locations

US (1)