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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Eicosapentaenoic acid free fatty acid
Placebo
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Neoplasms, Fish Oils, Fatty Acids, Omega-3, Eicosapentaenoic Acid, Liver Metastases, Randomised Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Eicosapentaenoic acid free fatty acid

Arm Description

2 capsules twice daily

2g daily (2 x 500mg capsules twice daily)

Outcomes

Primary Outcome Measures

Histological Ki67 cancer cell proliferation index

Secondary Outcome Measures

Histological neo-CK18 cancer cell apoptosis index
Histological tumour CD31-positive cell microvessel density
Safety and tolerability of EPA treatment
Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels
Plasma markers of prostaglandin metabolism
Platelet aggregation
Urinary markers of prostaglandin metabolism

Full Information

First Posted
February 12, 2010
Last Updated
October 20, 2011
Sponsor
University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT01070355
Brief Title
Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases
Acronym
EMT
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Neoplasms, Fish Oils, Fatty Acids, Omega-3, Eicosapentaenoic Acid, Liver Metastases, Randomised Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 capsules twice daily
Arm Title
Eicosapentaenoic acid free fatty acid
Arm Type
Active Comparator
Arm Description
2g daily (2 x 500mg capsules twice daily)
Intervention Type
Drug
Intervention Name(s)
Eicosapentaenoic acid free fatty acid
Other Intervention Name(s)
ALFA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 capsules taken twice daily for 2-6 weeks before liver resection.
Primary Outcome Measure Information:
Title
Histological Ki67 cancer cell proliferation index
Time Frame
at surgery 2-6 weeks after randomisation
Secondary Outcome Measure Information:
Title
Histological neo-CK18 cancer cell apoptosis index
Time Frame
at surgery 2-6 weeks after randomisation
Title
Histological tumour CD31-positive cell microvessel density
Time Frame
at surgery 2-6 weeks after randomisation
Title
Safety and tolerability of EPA treatment
Time Frame
Every 2 weeks whilst patient is taking study medication
Title
Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels
Time Frame
at surgery 2-6 weeks after randomisation
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Hull, PhD, FRCP
Organizational Affiliation
Leeds Institute of Molecular Medicine, University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leeds Institute of Molecular Medicine, St James's University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24470281
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.
Results Reference
derived

Learn more about this trial

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

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