Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer (NCT01975363) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer
United States29 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range19 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 requi…
What they're measuring
1
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
Trial details
NCT IDNCT01975363
SponsorOhio State University Comprehensive Cancer Center