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Atorvastatin ± Aspirin for Colorectal Cancer Prevention for People with Lynch Syndrome

Atorvastatin ± Aspirin for Colorectal Cancer Prevention for People with Lynch Syndrome

Clinicaltrials.gov identifier:
NCT04379999

Prevention:
Colorectal

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 (a nonsteroidal anti-inflammatory drug) in preventing colorectal cancer in people with Lynch syndrome. Atorvastatin may lower the risk of developing cancers in the colon and rectum. Aspirin may reduce the risk of colon polyps and colon cancers. Giving atorvastatin and aspirin may work better at reducing the risk of colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.
 

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 polyps 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 polyps 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   

This Study is Open To:

Men and women between ages 18 years to 75 years can be considered for enrollment in this study if they have:

  • Lynch Syndrome (mutation in MLH1, MSH2, MSH6, EPCAM or PMS2)
  • A history of colorectal cancer, are surgically cured, and are more than 1 year out from completion of adjuvant chemotherapy
This Study is Not Open To:
  • Active cancer or are less than 3 years post hormonal maintenance therapy for cancer
  • Have statin intolerance or contraindication (a reason for a person not to take) for aspirin or atorvastatin use