Breast Cancer Clinical Trial
Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer
Summary
This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of developing breast cancer.
Full Description
PRIMARY OBJECTIVES:
i.) To determine whether nanoemulsion curcumnin modulates pro-inflammatory biomarkers in plasma and breast adipose tissue.
SECONDARY OBJECTIVES include:
ii.) To determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC) in women at high risk for developing breast cancer;
iii.) Evaluate possible correlations between physical factors such as body mass index (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.
iv.) Explore additional biomarkers as surrogate endpoints to measure effects of NEC.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive lower dose of nanoemulsion curcumin orally (PO) twice daily (BID) for 3 months.
ARM II: Participants receive 100 mg of nanoemulsion curcumin PO BID for 3 months.
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
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There is 1 Location for this study
Columbus Ohio, 43210, United States
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