Atorvastatin ± Aspirin for Colorectal Cancer Prevention for People with Lynch Syndrome
Clinicaltrials.gov identifier:
NCT04379999
Prevention
Study Contact Information:
Contact: Yana Chertock, MA by phone: 215-214-3216 or by email
Atorvastatin ± Aspirin for Colorectal Cancer Prevention for People with Lynch Syndrome
About the Study
This study will look at how well atorvastatin (a common cholesterol lowering agent) works with or without aspirin in preventing colorectal cancer in people with . Atorvastatin may lower the risk of developing cancers in the colon and rectum. Aspirin may reduce the risk of colon and colon cancers. Giving atorvastatin and aspirin may work better at reducing the risk of colorectal cancer (CRC) in high-risk individuals with .
What the Study Entails
Participants in this study will be divided into two groups based on their prior history of polyps/cancer. Both the researchers and the participants will know about the treatment being administered to each group.
At entry to the study, all participants will undergo a colonoscopy and biopsy of normal tissue.
- Group 1: Patients with no history of colorectal cancer and no colorectal within 5 years will receive Atorvastatin (LIPITOR) 20 mg tablet daily for 6 weeks.
- Group 2: Patients with a history of colorectal cancer and/or history of colorectal within 5 years will receive Atorvastatin (LIPITOR) 20 mg tablet and Aspirin 325 mg tablet daily for 6 weeks
After 6 weeks of taking prescribed drugs, study participants will undergo a second colonoscopy and biopsy of normal tissue.
Study Site
Philadelphia, Pennsylvania
Fox Chase Cancer Center
Contact: Yana Chertock, MA by phone: 215-214-3216 or by email
Contact: Michael Hall, MD, MS by phone: 215-728-2791 or by email
Men and women between ages 18 years to 75 years can be considered for enrollment in this study if they have:
- (mutation in , , , or )
- A history of colorectal cancer, are surgically cured, and are more than 1 year out from completion of
- Active cancer or are less than 3 years post hormonal for cancer
- Have statin intolerance or contraindication (a reason for a person not to take) for aspirin or atorvastatin use