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HMG-CoA Reductase Inhibitor

Atorvastatin ± Aspirin for Lynch Syndrome

Phase < 1
Recruiting
Led By Michael J Hall, MD, MS
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a cholesterol-lowering drug (atorvastatin) alone or with a pain reliever (aspirin) can reduce colon cancer risk in people with Lynch syndrome. These individuals are at high risk for colon cancer. The study will look at how these drugs affect cell growth, death, and gene changes in the colon. Statins have anticancer activity in various cell types, including colon cancer cells.

Who is the study for?
This trial is for adults over 18 with Lynch Syndrome, a genetic condition raising colorectal cancer risk. Participants must understand English to give informed consent and have no active cancer or recent hormonal therapy. Those with statin intolerance, aspirin contraindications, or who are pregnant/breastfeeding cannot join.
What is being tested?
The study tests if Atorvastatin (a cholesterol-lowering drug), alone or combined with Aspirin (an anti-inflammatory drug), can lower the risk of colorectal cancer in individuals at high risk due to Lynch Syndrome.
What are the potential side effects?
Possible side effects include muscle pain, liver function changes from Atorvastatin, and gastrointestinal issues like stomach ulcers or bleeding from Aspirin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Genome-wide expression analyses using RNA-Seq
Proliferation (Ki-67) and apoptosis (active caspase 3) by immunohistochemical staining
Secondary study objectives
Interventional procedure
Frequency of adverse events among patients administered atorvastatin ± aspirin for 6 weeks
Rate of adherence of healthy patients with Lynch Syndrome to a 6-week of the treatment regimen (atorvastatin ± aspirin).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Atorvastatin and AspirinActive Control1 Intervention
Atorvastatin (LIPITOR) 20 milligram tablet and Aspirin 325 mg tablet daily for 6 weeks
Group II: AtorvastatinActive Control1 Intervention
Atorvastatin (LIPITOR) 20 milligram tablet daily for 6 weeks

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,327 Total Patients Enrolled
Michael J Hall, MD, MSPrincipal InvestigatorFox Chase Cancer Center

Media Library

Atorvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04379999 — Phase < 1
Colorectal Cancer Research Study Groups: Atorvastatin and Aspirin, Atorvastatin
Colorectal Cancer Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT04379999 — Phase < 1
Atorvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04379999 — Phase < 1
~1 spots leftby Dec 2024
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