drugset / Trial / NCT03428477

EPA for Metastasis Trial 2

NCT03428477

RandomizedParallel-groupQuadruple-blindPrevention

Summary

A significant proportion of patients who undergo liver surgery to remove bowel cancer that has spread to the liver (metastases) develop disease recurrence and die from the disease. A previous small study (the EMT study) suggested a possible survival benefit in patients who took the naturally-occurring omega-3 fatty acid EPA (a fish oil supplement) before liver surgery. The EMT2 study is a larger study which will recruit 448 men and women with liver metastases from bowel cancer. Trial participants will receive either Icosapent Ethyl (pure EPA derived from fish oil) or placebo (dummy capsules). EMT2 will investigate whether patients who take this supplement before liver surgery and for up to four years after surgery, remain free of recurrence for longer than those who take placebo (dummy capsules)

Timeline

Start
2018-05-02
Primary completion
2025-11-30
Completion
2026-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject icosapent ethyl Small molecule 4 g Oral