Clinical trial NCT01975363: Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer
Official title: Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atypical Ductal Breast Hyperplasia
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Ductal Breast Carcinoma in Situ
Lobular Breast Carcinoma in Situ
Keywords: Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 29
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Primary outcomes:
measure: Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.
timeFrame: Up to 3 months
Secondary outcomes:
measure: Evaluate possible correlations between physical factors such as body mass (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Steven Clinton, MD
role: PRINCIPAL_INVESTIGATOR
References: