Status:
COMPLETED
Soy Protein and Breast Cancer Risk Reduction
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
National Center for Research Resources (NCRR)
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-40 years
Phase:
PHASE2
Brief Summary
Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis tha...
Detailed Description
The aims will be tested by conducting 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 two differe...
Eligibility Criteria
Inclusion
- healthy premenopausal women
- 30 to 40 years old
- normal mammograms
- regular menstrual cycles
Exclusion
- abnormal mammograms
- first degree relatives with breast cancer
- pregnant or lactating
- peri- or post-menopause
- breast augmentation, reduction, and lifting
- on oral contraceptive medications or exogenous hormones
- medically prescribed diets
- allergic reaction to soy or cow's milk
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2023
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00204477
Start Date
April 1 2002
End Date
May 29 2023
Last Update
January 23 2024
Active Locations (1)
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1
General Clinical Research Center, The University of Texas Medical Branch
Galveston, Texas, United States, 77555-0264