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

Completed · Not applicable

Conditions studied: Atypical Ductal Breast Hyperplasia, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ

In brief

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.

Key facts

Study ID

NCT01975363

Run by

Ohio State University Comprehensive Cancer Center

People needed

29

Starts

2013-06-01

Expected to finish

2016-09-19

Last updated by the study team

2019-08-30

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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