EPA for Metastasis Trial 2

• Status: Recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mark A Hull, PhD FRCP; University of Leeds
• Collaborators: Amarin Pharma Inc.; Yorkshire Cancer Research
• Treatments: Eicosapentaenoic acid ethyl ester

Criteria

Inclusion Criteria:

• Aged ≥ 18 years

• Able to provide written informed consent

• Histological diagnosis of colorectal cancer with evidence of liver metastases

• Planned liver resection surgery for colorectal cancer liver metastases with curative intent, including repeat 're-do' colorectal cancer liver metastases surgery (a second independent resection for a separate colorectal cancer liver recurrence)

• Intention to receive IMP prior to colorectal cancer liver metastases surgery

Exclusion Criteria:

• Previous CRCLM surgery for the management of the current metastatic disease

• Incurable extra-hepatic metastases

• Current (in the last 2 months) or planned regular (>3 doses per week) use of O3FA-containing drugs or supplements, including Vazkepa®, Omacor®, fish oil and cod-liver oil supplements

• Fish/seafood allergy

• Diagnosis of hereditary fructose intolerance

• Soya or peanut allergy

• Inability to comply with trial treatment and follow-up schedule

• Known bleeding tendency/condition (e.g. von Willebrand disease)

• A previous malignancy within the last 5 years other than:

• colorectal cancer

• non-melanoma skin cancer where treatment consisted of resection only or radiotherapy

• ductal carcinoma in situ (DCIS) where treatment consisted of resection only

• cervical carcinoma in situ where treatment consisted of resection only

• superficial bladder carcinoma where treatment consisted of resection only

• A previous malignancy where the patient has been disease free for ≤ 5 years

• Pregnant or breastfeeding women or women of childbearing potential not willing to use effective contraceptive measures. Women of childbearing potential are defined as fertile, following menarche and until becoming post-menopausal, unless permanently sterile

• Men defined as fertile (post-pubescent and not permanently sterile by vasectomy or bilateral orchidectomy) and not willing to use effective contraceptive measures if appropriate.