National polyp prevention trial needs participants

Do cholesterol-lowering drugs help prevent CRC?

You might be able to help answer that question. A national research project needs people who have been treated for early-stage (stage I or II) colorectal cancer in the past year.

There have been tantalizing hints that cholesterol-lowering drugs (statins) might help prevent the growth of precancerous (adenomatous) polyps and/or recurrent colorectal cancer. Millions of Americans already take these statins to protect against heart attacks. We also know that people who have had early-stage colorectal cancer have up to a 50% chance of developing new polyps within 3 years.

Some studies have shown that people who had taken statins had lower rates of colorectal cancer (CRC), but other studies did not. And all of those studies were fairly short-term, looking for heart events rather than slower-developing cancers. So the jury is still out.

In 2010, the first national study was launched designed specifically to see if cholesterol-lowering statins could prevent colorectal cancer. But researchers still need more participants from all over the US, especially those at relatively high risk of developing cancerous polyps.

This NSABP trial (by the National Surgical Adjuvant Breast and Bowel Project) is the first national study aimed at testing a possible way to prevent the formation of adenomatous polyps and either recurrent or new colorectal cancer. It is a carefully designed, Phase III prospective trial—meaning it looks forward to see if a specific drug changes the rate of polyps and/or colorectal cancers that occur. To get a clearer, faster answer, the trial focuses on people at especially high risk of developing colorectal tumors—those who have already been treated for early-stage colorectal cancer.

Although surgical removal can cure most patients with stage I or II CRC, as many as 50 percent will develop a new tumor (mostly adenomatous or precancerous polyps) within 3 years. Some will even develop a second, new cancer of the colon or rectum.

Trial participants will have physical exams every 6 months, colonoscopies at 6 months, 1, 3 and 5 years. Half will take the statin drug rosuvastatin (Crestor) for a minimum of five years, while others will take a placebo.

Eligible participants must have had stage I or II CRC surgically removed within the past year and are finished with chemotherapy. People with Lynch syndrome, FAP, or ulcerative colitis will not be included in this trial, nor will those who have already taken cholesterol-lowering statins. However, the trial will accept people already taking low-dose aspirin to prevent heart disease.

“We’re also very interested in aspirin, because we know that it has some benefit in preventing colorectal polyps and cancer,” said lead investigator Dr. Bruce M. Boman, so the trial is designed to see whether taking statins or aspirin alone, or whether the drugs taken together can prevent polyps and CRC.

The trial is being conducted in more than 500 cancer centers nationwide. If you or someone you know might be eligible and willing to help move the science forward, call the Fight Colorectal Cancer Answer Line (1-877-427-2111) or email an Answer Line Associate.

Source: National Cancer Institute