Skip to main content
OpenTrials
Completed

NCT Number: NCT01070355

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Leeds, West Yorkshire, LS9 7TF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Eicosapentaenoic acid free fatty acid

Drug

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.

Other names: ALFA

Placebo

Drug

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

Primary outcomes

  1. Histological Ki67 cancer cell proliferation index

    Time frame: at surgery 2-6 weeks after randomisation

Secondary outcomes

  1. Histological neo-CK18 cancer cell apoptosis index

    Time frame: at surgery 2-6 weeks after randomisation

  2. Histological tumour CD31-positive cell microvessel density

    Time frame: at surgery 2-6 weeks after randomisation

  3. Safety and tolerability of EPA treatment

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

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

    Time frame: at surgery 2-6 weeks after randomisation

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Official study title

The Effects of Eicosapentaenoic Acid (EPA) on Biomarkers of Growth and Vascularity in Human Colorectal Cancer Liver Metastases (The EPA for Metastasis Trial)

Acronym: EMT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2010
Registry last updated
Oct 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.