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
Up to 30 women will participate in this phase I prevention clinical trial. Women with a body mass index (BMI) over 30 who have been deemed at increased risk for developing breast cancer based on family or personal medical history may qualify for this prevention clinical trial.
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
The Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute strives to create a cancer-free world by integrating scientific research with excellence in education and patient-centered care, a strategy that leads to better methods of prevention, detection and treatment. Ohio State is one of only 41 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers and one of only four centers funded by the NCI to conduct both phase I and phase II clinical trials. The NCI recently rated Ohio State's cancer program as "exceptional," the highest rating given by NCI survey teams. As the cancer program's 228-bed adult patient-care component, The James is a "Top Hospital" as named by the Leapfrog Group and one of the top cancer hospitals in the nation as ranked by U.S.News & World Report.
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