NCT03428477Active, not recruitingPhase 3
EPA for Metastasis Trial 2
A Randomised Placebo-controlled Phase III Trial of the Effect of the Omega-3 Fatty Acid Eicosapentaenoic Acid (EPA) on Colorectal Cancer Recurrence and Survival After Surgery for Resectable Liver Metastases
Source: ClinicalTrials.gov · Last updated 18 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 418 (actual)
- First submitted
- 11 Jan 2018
- Start date
- 2 May 2018
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Mark A Hull, PhD FRCP
- Diseases
- Colorectal cancer
- NCT number
- NCT03428477
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 418
- From 2 May 2018 to the primary completion date, 30 Nov 2025
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous CRCLM surgery for the management of the current metastatic disease
- 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
Other illness
- Fish/seafood allergy
- Soya or peanut allergy
- 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
Age
- A previous malignancy where the patient has been disease free for ≤ 5 years
Other
- Incurable extra-hepatic metastases
- Diagnosis of hereditary fructose intolerance
- Inability to comply with trial treatment and follow-up schedule
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aintree University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Aintree | United Kingdom | Unknown status |
| Hampshire Hospitals Nhs Foundation Trust Coordinator of this site? Confirm its status | Basingstoke | United Kingdom | Unknown status |
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Cambridge UniversityHospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Leeds Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Royal Free London NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Newcastle Upon Tyne Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Oxford University Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
Related publications
- Randomised, placebo-controlled, phase 3 trial of the effect of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) on colorectal cancer recurrence and survival after surgery for resectable liver metastases: EPA for Metastasis Trial 2 (EMT2) study protocol.BMJ Open · 2023 · PMID 38030258
This page is information, not medical advice. Discuss any trial with your doctor.