Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer

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.

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