Clinical trial NCT01070355: Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases
Official title: The Effects of Eicosapentaenoic Acid (EPA) on Biomarkers of Growth and Vascularity in Human Colorectal Cancer Liver Metastases (The EPA for Metastasis Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colorectal Neoplasms
Fish Oils
Fatty Acids, Omega-3
Eicosapentaenoic Acid
Liver Metastases
Randomised Controlled Trial
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Histological Ki67 cancer cell proliferation index
timeFrame: at surgery 2-6 weeks after randomisation
Secondary outcomes:
measure: Histological neo-CK18 cancer cell apoptosis index
timeFrame: at surgery 2-6 weeks after randomisation
measure: Histological tumour CD31-positive cell microvessel density
timeFrame: at surgery 2-6 weeks after randomisation
measure: Safety and tolerability of EPA treatment
timeFrame: Every 2 weeks whilst patient is taking study medication
measure: Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels
timeFrame: at surgery 2-6 weeks after randomisation
measure: Plasma markers of prostaglandin metabolism
timeFrame: 1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)
measure: Platelet aggregation
timeFrame: 1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)
measure: Urinary markers of prostaglandin metabolism
timeFrame: 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)
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Institute of Molecular Medicine, St James's University Hospital
state: West Yorkshire
Study officials:
affiliation: Leeds Institute of Molecular Medicine, University of Leeds
name: Mark A Hull, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.