The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.
The investigators would like to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles. The investigators would also like to determine if Brevail® can reduce breast cell proliferation in pre-menopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
180
The placebo contains same filler materials as commercially available Brevail® but without active SDG.
1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Northwestern University Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Change in Percent of Breast Epithelial Cells With Ki-67 Immunocytochemical Expression
Change over the course of study in the percent of breast epithelial cells expressing the proliferation marker Ki- 67/MIB-1 in hyperplastic benign breast tissue acquired by random periareolar fine needle aspiration pre-study and post-study.
Time frame: 12 months
Change in Gene Expression
Gene expression in breast epithelial cells assessed by RT-qPCR. Change in expression (fold-change for 12-months compared to baseline value) was evaluated by cluster analysis and used to define "responders" and non-responders" based on favorable or non-favorable modulation of a set of 12 relevant genes. Specifically, data for change in ESR1 (codes for estrogen receptor alpha) are shown.
Time frame: 12 months
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
Quality of life as measured by the Breast Cancer Prevention Trial (BCPT) Symptom Checklist, completed at baseline and end of study by each participant. Responses to 43 questions (with each question given a value from 0 to 4, higher score being worse) are clustered into seven domains to yield an average score per domain. These seven category scores are then averaged to provide a final average score (range by definition, 0 to 4). Change in score over the course of the intervention per individual is then assessed. By definition, change in score theoretically ranges from -4 to +4.
Time frame: 12 months
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Ohio State Unviersity Medical Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Washington
Seattle, Washington, United States