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

University of Leeds88 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Colorectal Cancer

Interventions

Eicosapentaenoic acid free fatty acidDRUG

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.

PlaceboDRUG

2 capsules taken twice daily for 2-6 weeks before liver resection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Leeds Institute of Molecular Medicine, St James's University Hospital

Leeds, West Yorkshire, United Kingdom

Outcomes

Primary Outcomes

Histological Ki67 cancer cell proliferation index

Time frame: at surgery 2-6 weeks after randomisation

Secondary Outcomes

Histological neo-CK18 cancer cell apoptosis index

Time frame: at surgery 2-6 weeks after randomisation

Histological tumour CD31-positive cell microvessel density

Time frame: at surgery 2-6 weeks after randomisation

Safety and tolerability of EPA treatment

Time frame: Every 2 weeks whilst patient is taking study medication

Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels

Time frame: at surgery 2-6 weeks after randomisation

Plasma markers of prostaglandin metabolism

Time frame: 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

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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