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Sponsors and Collaborators: |
The University of Texas, Galveston National Cancer Institute (NCI) National Center for Research Resources (NCRR) |
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Information provided by: | The University of Texas, Galveston |
ClinicalTrials.gov Identifier: | NCT00204490 |
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 |
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Breast Cancer |
Dietary Supplement: isoflavones Dietary Supplement: carbohydrate |
Phase II |
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 |
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 |
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1: Experimental
soy isoflavones
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Dietary Supplement: isoflavones
soy isoflavones
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2: Placebo Comparator
carbohydrates
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Dietary Supplement: carbohydrate
carbohydrate
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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.
Ages Eligible for Study: | 30 Years to 42 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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. |
Principal Investigator: | Lee-Jane W Lu, Ph.D. | The University of Teas Medical Branch |
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 |
soy isoflavones phytoestrogens |
prevention mammographic density bone density |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |