Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Placebo; Drug: Eicosapentaenoic acid free fatty acid

• Registration Number: NCT01070355
• Lead Sponsor: University of Leeds

Brief Summary

Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found in oily fish. EPA has anti-colorectal (bowel) cancer activity in experimental models. This trial will test whether EPA reduces markers of tumour growth, and is safe and well tolerated,in patients with colorectal cancer liver metastases awaiting surgery.

Detailed Description

A double-blind, randomised, placebo-controlled trial of eicosapentaenoic acid (EPA), in the free fatty acid form, 2g daily in patients who will undergo liver resection surgery for colorectal cancer liver metastases.

Study Timeline

• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Study Start: 2010-04
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-20
• Last Update Posted: 2011-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Age greater than or equal to 18 years
• 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

• Neo-adjuvant chemotherapy for colorectal cancer (CRC) liver metastasis
• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 capsules twice daily
Eicosapentaenoic acid free fatty acid	Eicosapentaenoic acid free fatty acid	2g daily (2 x 500mg capsules twice daily)

Primary Outcome Measures

Name	Time	Method
Histological Ki67 cancer cell proliferation index	at surgery 2-6 weeks after randomisation

Secondary Outcome Measures

Name	Time	Method
Histological neo-CK18 cancer cell apoptosis index	at surgery 2-6 weeks after randomisation
Histological tumour CD31-positive cell microvessel density	at surgery 2-6 weeks after randomisation
Safety and tolerability of EPA treatment	Every 2 weeks whilst patient is taking study medication
Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels	at surgery 2-6 weeks after randomisation
Plasma markers of prostaglandin metabolism	1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)
Platelet aggregation	1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)
Urinary markers of prostaglandin metabolism	1. Baseline 2. after 2 weeks of study medication 3. after approx 4 weeks of study medication (immediately prior to surgery). 4. Six weeks after liver resection (no study medication)

Trial Locations

Locations (1)

Leeds Institute of Molecular Medicine, St James's University Hospital; 🇬🇧 Leeds, West Yorkshire, United Kingdom