Soy Isoflavones and Breast Cancer Risk Reduction

Breast Cancer Clinical Trial

Official title:

Mammographic Density and Soy Isoflavones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204490
• Other study ID #: 03-260
• Secondary ID: UTMB GCRC #635R0
• Status: Completed
• Phase: Phase 2
• Start date: April 2004
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.

Description:

This is a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: May 31, 2023
• Est. primary completion date: December 10, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 42 Years

Eligibility

Inclusion Criteria:

• healthy premenopausal women

• 30 to 42 years old

• normal mammograms

• regular menstrual cycles

Exclusion Criteria:

• abnormal mammograms

• first degree relatives with breast cancer

• pregnant or lactating

• peri- or post-menopause

• breast augmentation, reduction or lifting

• on oral contraceptive medications or exogenous hormones

• medically prescribed diets

• allergic reaction to soy products

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• isoflavones
soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.
• carbohydrate
carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.

Locations

Country	Name	City	State
United States	General Clinical Reserach Center, The University of Texas Medical Branch	Galveston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Cancer Institute (NCI), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibroglandular Tissue in Total Breast (FGBT%)	Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.	baseline, and after year 1 and 2 of supplementation
Primary	Breast Density by Mammography	Area of FGBT in mammogram. The timepoints were combined and summed.	baseline, and after year 1 and 2 of supplementation
Secondary	Bone Mineral Density	Bone mineral density of hip, spine and whole body bone mineral density as measured by dual x-ray absorptiometry. The timepoints were combined and summed.	one and two years after dietary supplement