University of Cincinnati (UC) Cancer Institute oncologists are testing whether a widely used cholesterol-reducing drug can help prevent the recurrence of colorectal cancer in patients who have been surgically treated for the disease previously.
This seven-year trial will assess whether taking statins -- a class of cholesterol-lowering drugs that target enzymes in the liver -- can prevent the formation of polyps and, therefore, prevent colorectal cancer recurrence in people with previous colorectal cancers that have been removed surgically.
"Statins help regulate enzymes in the body that govern inflammation, and preliminary studies suggest they may also be helpful in the reduction of colorectal and bowel cancer, explains Elizabeth Shaughnessy, MD, PhD, an associate professor at the UC College of Medicine and surgical oncologist with UC Health.
This national prevention trial is sponsored by the National Surgical and Adjuvant Bowel and Breast Project (NSABP), a clinical trials cooperative research group supported by the National Cancer Institute (NCI). Shaughnessy serves as principal investigator for all NSABP research protocols conducted at UC.
Study participants will be randomized into one of two groups: The first group will receive a daily placebo (non-medicated pill); the second will take a statin medication called rosuvastatin (marketed as Crestor) for five years. The drug is approved by the Food and Drug Administration (FDA) to slow the production of cholesterola fatty substance in the blood linked to heart diseasein the body.
"The medication rosuvastatin was chosen for this prevention trial because it posed the lowest risk of side effects to patients, says Shaughnessy.
Researchers hope to recruit about 1,700 people from across the United States. Patients are being recruited at nearly 400 centers nationwide, including the UC Health Barrett Cancer Center in Clifton and UC Health Physicians Office in West Chester. Approximately 50 patients are expected to join the UC-based arm of the trial.
Patients with previous stage 1 or 2 colorectal cancers who have been treated surgically within one year of trial enrollment may qualify for this study. People on other statin drugs cannot participate in the trial.
Signs of cancer recurrence will be monitored with regular physician exams, blood tests and periodic colonoscopies. The last two years will be active follow-up to monitor any cancer recurrence.
Colon cancer forms in the tissue of the colon, the longest part of the large intestine. Rectal cancer forms in the last several inches of the large intestine, closest to the anal opening. According to NCI, more than 154,000 people will be diagnosed with colon or rectal cancer (102,900 colon, 36,670 rectal) in 2011. It is the second-leading cause of cancer-related death in the United States.
"The good news is that most colorectal cancers have a pre-cancerous stage, says UC Health colorectal surgeon Bradley Davis, MD. Davis is also an assistant professor at the UC College of Medicine. "People can also reduce their risk for the diseaseas well as many other health problemsby making healthy lifestyle changes: ceasing to smoke, maintaining a healthy weight, exercising and avoiding alcohol consumption.
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