Using atorvastatin and aspirin to reduce colorectal cancer risk in Lynch syndrome
Impact of Atorvastatin ± Aspirin on Colorectal Biomarkers in Patients With Lynch Syndrome: a Pilot Study
This study is testing if taking atorvastatin alone or with aspirin can lower the risk of colorectal cancer in people with Lynch syndrome.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fox Chase Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04379999 on ClinicalTrials.gov |
What this trial studies
This exploratory biomarker trial aims to evaluate the effectiveness of atorvastatin, a common cholesterol-lowering medication, alone or in combination with aspirin, a nonsteroidal anti-inflammatory drug, in reducing the risk of colorectal cancer in individuals with Lynch syndrome. Participants will be stratified based on their history of polyps or cancer and will receive treatment for 6 weeks. Blood samples and normal colon biopsies will be collected at the start and end of the treatment period to assess various biological markers and changes in gene expression. The study will also evaluate the acceptability of the treatment through post-treatment questionnaires.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with molecular evidence of Lynch syndrome and a history of colorectal cancer that has been surgically cured.
Not a fit: Patients with active cancer, those under 18, or individuals with contraindications to atorvastatin or aspirin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive strategy for colorectal cancer in high-risk individuals with Lynch syndrome.
How similar studies have performed: While this approach is novel in the context of Lynch syndrome, similar studies have explored the use of atorvastatin and aspirin in cancer prevention with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michael J Hall, MD, MS — Fox Chase Cancer Center
- Study coordinator: Yana Chertock, MA
- Email: yana.chertock@fccc.edu
- Phone: 215-214-3216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.