29
Participants
Start Date
June 30, 2013
Primary Completion Date
September 19, 2016
Study Completion Date
September 19, 2016
curcumin
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
Biomarker analysis
Breast adipose tissue and plasma samples will be obtained at baseline and 3 months for biomarker analyses. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin/COG and also stored at -80°C for biomarker analyses.
Assessment of Dietary Intake
Food frequency questionnaires will be obtained at 0 months and 24-hour dietary recalls will be obtained at 1, 2 and 3 months of the study.
Daily Log
All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus
Ohio State University Comprehensive Cancer Center
OTHER