Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases
NCT ID: NCT01070355
Last Updated: 2011-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2010-04-30
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
2 capsules twice daily
Placebo
2 capsules taken twice daily for 2-6 weeks before liver resection.
Eicosapentaenoic acid free fatty acid
2g daily (2 x 500mg capsules twice daily)
Eicosapentaenoic acid free fatty acid
An enteric-coated preparation of 99% pure omega-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid as the free fatty acid. 500mg capsules, 2 taken twice daily for 2-6 weeks before liver resection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eicosapentaenoic acid free fatty acid
An enteric-coated preparation of 99% pure omega-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid as the free fatty acid. 500mg capsules, 2 taken twice daily for 2-6 weeks before liver resection.
Placebo
2 capsules taken twice daily for 2-6 weeks before liver resection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Either sex
* Liver resection deemed clinically appropriate for management of metastatic colorectal cancer
* Duration between decision to perform liver resection and surgery greater than 2 weeks
* Ability to give written informed consent and follow study protocol
* Telephone contact possible
Exclusion Criteria
* Chemotherapy for any cancer in the previous 3 months
* Known bleeding diathesis or anticoagulation therapy
* Fish or seafood allergy
* Use of fish oil supplements (eg. cod liver oil) and unwilling to stop for the duration of the study
* Pregnancy
* Non-aspirin non-steroidal anti-inflammatory (NSAID) or corticosteroid use
* Renal impairment (serum creatinine \>150)
* Active inflammatory disease (e.g. Inflammatory Bowel Disease, Rheumatoid Arthritis).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Leeds
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mark Hull
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark A Hull, PhD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Leeds Institute of Molecular Medicine, University of Leeds
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Leeds Institute of Molecular Medicine, St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cockbain AJ, Volpato M, Race AD, Munarini A, Fazio C, Belluzzi A, Loadman PM, Toogood GJ, Hull MA. Anticolorectal cancer activity of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid. Gut. 2014 Nov;63(11):1760-8. doi: 10.1136/gutjnl-2013-306445. Epub 2014 Jan 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-015903-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA09/9094
Identifier Type: -
Identifier Source: org_study_id