Name of the Trial
Phase II Chemoprevention Study of Curcumin in Current Smokers with Aberrant Crypt Foci (UCIRVINE-UCI04-2-01). See the protocol summary at http://cancer.gov/clinicaltrials/UCIRVINE-UCI04-2-01.

Principal Investigators
Dr. Richard Banya, University of Illinois at Chicago; Dr. D. Kim Turgeon, University of Michigan; and Dr. Frank Meyskens, University of California, Irvine

Why This Trial Is Important
Colorectal cancer remains the second leading cause of cancer death in the United States despite effective screening methods and proven therapies. In an effort to reduce colorectal cancer incidence and death, researchers are exploring ways to prevent the disease using drugs or other chemicals (chemoprevention).

Microscopic lesions in the lining of the colon called aberrant crypt foci (ACF) are thought to be precursors of colon polyps and, ultimately, malignant tumors. ACF lesions typically display biomarkers that may indicate precancerous development. In this trial, researchers are exploring the ability of a substance called curcumin to affect these biomarkers and possibly stop the progression to cancer. Curcumin is a component of turmeric, a spice commonly used in curry powder.

Doctors are interested in determining whether curcumin supplements taken for 30 days can help reduce the levels of precancerous biomarkers in the ACF of smokers who have eight or more lesions. Smoking is a known risk factor for colon cancer, and studies suggest that as many as 80 percent of smokers have ACF lesions.

"Though it has been used for centuries in traditional medicine, we're very early in the clinical development of curcumin as a chemopreventive agent," Dr. Meyskens said. "This trial is a proof-of-principle study to see if curcumin really can affect the relevant biomarkers in humans. If it does, we can then design a larger cancer prevention trial based on demonstrated biological response rather than on results from epidemiological studies."

Who Can Join This Trial
Researchers will enroll 48 current smokers with at least 8 aberrant crypt foci. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/UCIRVINE-UCI04-2-01.

Study Sites and Contact Information
Study sites in Illinois and Michigan are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/UCIRVINE-UCI04-2-01 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.