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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01070355

First Posted: February 18, 2010

Last Update Posted: October 21, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Mark Hull, University of Leeds

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: Eicosapentaenoic acid free fatty acid Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Colorectal Cancer

Drug Information available for: Icosapent Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Mark Hull, University of Leeds:

Primary Outcome Measures:

Histological Ki67 cancer cell proliferation index [ Time Frame: at surgery 2-6 weeks after randomisation ]

Secondary Outcome Measures:

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) ]


Enrollment:	88
Study Start Date:	April 2010
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo 2 capsules twice daily	Drug: Placebo 2 capsules taken twice daily for 2-6 weeks before liver resection.
Active Comparator: Eicosapentaenoic acid free fatty acid 2g daily (2 x 500mg capsules twice daily)	Drug: 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. Other Name: ALFA

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070355

Locations


United Kingdom
Leeds Institute of Molecular Medicine, St James's University Hospital
Leeds, West Yorkshire, United Kingdom, LS9 7TF

Sponsors and Collaborators

University of Leeds

Investigators


Principal Investigator:	Mark A Hull, PhD, FRCP	Leeds Institute of Molecular Medicine, University of Leeds

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Mark Hull, Professor, University of Leeds
ClinicalTrials.gov Identifier:	NCT01070355 History of Changes
Other Study ID Numbers:	GA09/9094 2009-015903-22 ( EudraCT Number )
First Submitted:	February 12, 2010
First Posted:	February 18, 2010
Last Update Posted:	October 21, 2011
Last Verified:	October 2011

Keywords provided by Mark Hull, University of Leeds:


Colorectal Neoplasms Fish Oils Fatty Acids, Omega-3	Eicosapentaenoic Acid Liver Metastases Randomised Controlled Trial

Additional relevant MeSH terms:


Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes

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