Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer
Atypical Ductal Breast Hyperplasia, BRCA1 Gene Mutation, BRCA2 Gene Mutation
About this trial
This is an interventional prevention trial for Atypical Ductal Breast Hyperplasia focused on measuring Breast Cancer
Eligibility Criteria
INCLUSION CRITERIA:
- Increased risk for breast cancer based on family history, personal history
- Normal mammogram, clinical breast examination in the past 12 months
- >1 year from pregnancy, lactation or chemotherapy
- Body mass index (BMI) between 25 - 40
EXCLUSION CRITERIA:
- Concurrent malignancy or metastatic malignancy of any kind
- Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
- History of a bleeding tendency or current use of Coumadin or other anticoagulants
- Current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (HIV) infection
- Pregnant or lactating women
- Concurrent use of hormonal contraception or hormone replacement therapy
- Concurrent use of immunosuppressant medications
- Concurrent use of medications known to inhibit or induce hepatic enzyme cytochrome P450 (CYP) 3A4
- Barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (FNA) sampling
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements
- Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with NEC
- Known sensitivity or allergy to turmeric spices or curry
- Dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis
- Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (NSAID)s or NSAID-containing products
Sites / Locations
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (lower dose curcumin)
Arm II (higher dose curcumin)
Participants receive 50 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Assessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
Participants receive 100 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Asssessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.