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Soy Isoflavones and Breast Cancer Risk Reduction
This study is currently recruiting participants.
Verified by The University of Texas, Galveston, June 2008
Sponsors and Collaborators: The University of Texas, Galveston
National Cancer Institute (NCI)
National Center for Research Resources (NCRR)
Information provided by: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00204490
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Dietary Supplement: isoflavones
Dietary Supplement: carbohydrate
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Dietary Supplements
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Mammographic Density and Soy Isoflavones

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Breast density [ Time Frame: one or two years after dietary supplements ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bone density [ Time Frame: one or two years after dietary supplement ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2004
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
soy isoflavones
Dietary Supplement: isoflavones
soy isoflavones
2: Placebo Comparator
carbohydrates
Dietary Supplement: carbohydrate
carbohydrate

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204490

Contacts
Contact: Lee-Jane W Lu, Ph.D. 409 772 4661 llu@utmb.edu
Contact: Karl E Anderson, M.D. 409 772 4661 kanderso@utmb.edu

Locations
United States, Texas
General Clinical Reserach Center, The University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0264
Contact: Lee-Jane W Lu, Ph.D.     409-772-4661     llu@utmb.edu    
Contact: Elizabeth B Ruiz     409 772 1950     ebruiz@utmb.edu    
Principal Investigator: Lee-Jane W Lu, Ph.D.            
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Lee-Jane W Lu, Ph.D. The University of Teas Medical Branch
  More Information

Responsible Party: University of Texas Medical Branch ( Lee Jane Lu/Professor )
Study ID Numbers: 03-260, UTMB GCRC #635, NIH R01-CA95545, NIH NCRR GCRC M01 RR00073
Study First Received: September 12, 2005
Last Updated: June 6, 2008
ClinicalTrials.gov Identifier: NCT00204490  
Health Authority: United States: Federal Government

Keywords provided by The University of Texas, Galveston:
soy
isoflavones
phytoestrogens
prevention
mammographic density
bone density

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009