NCT04379999

Atorvastatin ± Aspirin in Lynch Syndrome Syndrome

Impact of Atorvastatin ± Aspirin on Colorectal Biomarkers in Patients With Lynch Syndrome: a Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.

Detailed description

This is an exploratory biomarker trial to assess the ability of atorvastatin (common cholesterol lowering agent) alone or combining with aspirin (a nonsteroidal anti-inflammatory drug) to reduce the risk of colorectal cancer in high-risk individuals with Lynch Syndrome. Subjects will be stratified based on their prior history of polyps/cancer to receive atorvastatin without or with aspirin for 6 weeks. Blood and normal colon biopsies will be obtained at Day 0 and at 6 weeks on study. Tissue endpoints for analysis include cell proliferation, apoptosis and changes in gene expression. Circulating lipid profiles and metabolic function, and post-treatment questionnaires will be used to assess the acceptability of the study.

Conditions

• Lynch Syndrome

Interventions

Type	Name	Description
DRUG	Atorvastatin 20mg	No history of colorectal cancer and no colorectal adenomas within 5 years.
DRUG	Atorvastatin 20mg AND Aspirin 325 mg	History of colorectal cancer and/or history of colorectal adenomas within 5 years.

Timeline

• Start date: 2018-09-10
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2020-05-08
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study