Clinical trial NCT00204477: Soy Protein and Breast Cancer Risk Reduction
Official title: Soybean Diet and Breast Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: soy diet
breast cancer
ovarian hormones
breast density
prevention
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: National Center for Research Resources (NCRR)
First posted: 2005-09-20
Enrollment: 321
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo controlled, 2 parallel groups
Primary purpose: TREATMENT

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 that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.

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 different dietary supplements daily for 2 years. The two test diets soy protein drink and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary intervention period and analyzed for ovarian hormones. At baseline and after the intervention period, breast density, and bone density will be assessed by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids, and density of the breast and bone tissues over the 2 year dietary intervention period in the two diet groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soya dietary supplements will reduce breast density, which will be explained by individual hormonal changes.

Eligibility criteria: Inclusion Criteria:

* healthy premenopausal women
* 30 to 40 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, and lifting
* on oral contraceptive medications or exogenous hormones
* medically prescribed diets
* allergic reaction to soy or cow's milk

Primary outcomes:
measure: Mammographic Density (Baseline)
timeFrame: Baseline
measure: Mammographic Density (1 Year)
timeFrame: 1 Year
measure: Mammographic Density (2 Years)
timeFrame: 2 years
measure: Breast Tissue Composition Measured by MRI
timeFrame: Baseline
measure: Breast Tissue Composition Measured by MRI
timeFrame: 1 Year
measure: Breast Tissue Composition Measured by MRI
timeFrame: 2 years
measure: Percentage of Grandular Tissue in Total Breast Measured by MRI
timeFrame: Baseline
measure: Percentage of Grandular Tissue in Total Breast Measured by MRI
timeFrame: 1 Year
measure: Percentage of Grandular Tissue in Total Breast Measured by MRI
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Blood Will be Measured for Standard Clinical Chemistries
timeFrame: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.
measure: Progesterone (ng/ml)
timeFrame: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.
Locations:
city: Galveston
country: United States
facility: General Clinical Research Center, The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch, Galveston, TX 77555
name: Lee-Jane W Lu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu LJ, Nishino TK, Johnson RF, Nayeem F, Brunder DG, Ju H, Leonard MH, Grady JJ, Khamapirad T. Comparison of breast tissue measurements using magnetic resonance imaging, digital mammography and a mathematical algorithm. Phys Med Biol. 2012 Nov 7;57(21):6903-27. doi: 10.1088/0031-9155/57/21/6903. Epub 2012 Oct 9.
citation: Nayeem F, Anderson KE, Nagamani M, Grady JJ, Lu LJ. Alkaline phosphatase and percentage body fat predict circulating C-reactive protein in premenopausal women. Biomarkers. 2010 Dec;15(8):663-70. doi: 10.3109/1354750X.2010.509811. Epub 2010 Sep 29.