Atorvastatin ± Aspirin in Lynch Syndrome Syndrome

Temple University Health System (TUHS)

Status and phase: Completed; Early Phase 1

Conditions: Lynch Syndrome

Treatments: Drug: Atorvastatin 20mg AND Aspirin 325 mg; Drug: Atorvastatin 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04379999

18-1039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who are 18 years of age or older
• Able to read and sign an informed consent document in English
• Eligible subjects will have molecular evidence of Lynch Syndrome (mutation in MLH1, MSH2, MSH6, EPCAM or PMS2)
• History of colorectal cancer if surgically cured and > 1 year from completion of adjuvant chemotherapy

Exclusion criteria

• Are <18 years of age
• Unable to read and sign an informed consent document in English
• Have active cancer or are less than 3 years post hormonal maintenance therapy for cancer
• Have statin intolerance or contraindication for aspirin or atorvastatin use
• Are pregnant or are actively breast feeding

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Atorvastatin

Active Comparator group

Description:

Atorvastatin (LIPITOR) 20 milligram tablet daily for 6 weeks

Treatment:

Drug: Atorvastatin 20mg

Atorvastatin and Aspirin

Active Comparator group

Description:

Atorvastatin (LIPITOR) 20 milligram tablet and Aspirin 325 mg tablet daily for 6 weeks

Treatment:

Drug: Atorvastatin 20mg AND Aspirin 325 mg