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 range

19 Years

Sex

FEMALE

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09-19

View on ClinicalTrials.gov More Atypical Ductal Breast Hyperplasia trials