Developed by OSUCCC - James breast cancer researchers, the trial is led by principal investigator Lisa Yee, MD, a surgical oncologist with the OSUCCC-James Stefanie Spielman Comprehensive Breast Cancer Center.
"We are concerned that low-grade, chronic inflammation puts certain women at increased risk for breast cancer," Yee says. "We know that curcumin has potent anti-inflammatory properties. The challenge is that curcumin is minimally absorbed when eaten or taken as a pill, making it difficult to gauge its true potential as a cancer-prevention agent."
The new oral curcumin formulation - called "nanoemulsion curcumin" - is specifically designed to increase curcumin absorption in the body.
Zhongfa Liu, PhD, Ohio State College of Pharmacy research assistant professor, spearheaded the development of the nanoemulsion curcumin. Patty Havard, PharmD, Ohio State College of Medicine adjunct professor of obstetrics/gynecology and an associate professor at the University of Buffalo, developed the capsule dosage formulation and pharmacokinetics studies.
Study Qualifications, Process
Study participants will be randomized to receive either 100 or 50 milligrams of the investigational supplement two times a day for three months. Curcumin levels will be monitored through regular blood samples. Researchers will also collect small samples of breast fat to look for cellular changes. Throughout the trial, participants will also be asked to track daily food intake and complete dietary habit questionnaires.
Previous studies have evaluated curcumin dietary supplements for the treatment and prevention of diseases associated with inflammation, including arthritis, diabetes and cancer, but this is the first trial to evaluate this new formulation.
"This trial is part of an overarching research program to find ways to help reduce that risk through dietary and other non-toxic interventions," adds Yee.
The study is sponsored by the OSUCCC-James Molecular Carcinogenesis and Chemoprevention Program and Center for the Advancement of Functional Foods of The Ohio State University.
About the OSUCCC-James
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