ClinicalTrials.gov

History of Changes for Study: NCT01070355
Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases (EMT)
Latest version (submitted October 20, 2011) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 February 17, 2010 None (earliest Version on record)
2 February 25, 2010 Eligibility, Arms and Interventions and Study Status
3 April 22, 2010 Recruitment Status, Study Status and Contacts/Locations
4 October 18, 2010 Study Status
5 August 4, 2011 Recruitment Status, Study Status and Contacts/Locations
6 October 20, 2011 Recruitment Status, Sponsor/Collaborators, Study Status and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT01070355
Submitted Date:  February 17, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: GA09/9094
Brief Title: Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases (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)
Secondary IDs: 2009-015903-22 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2010
Overall Status: Not yet recruiting
Study Start: March 2010
Primary Completion: March 2011 [Anticipated]
Study Completion: August 2011 [Anticipated]
First Submitted: February 12, 2010
First Submitted that
Met QC Criteria:
February 17, 2010
First Posted: February 18, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 17, 2010
Last Update Posted: February 18, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Leeds
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Colorectal Cancer
Keywords: Colorectal Neoplasms
Fish Oils
Fatty Acids, Omega-3
Eicosapentaenoic Acid
Liver Metastases
Randomised Controlled Trial
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 88 [Anticipated]
Open or close this module Arms and Interventions
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 PUFA eicosapentaenoic acid as the free fatty acid. 500mg capsules, 2 taken twice daily for 2-6 weeks before liver resection.
Other Names:
  • ALFA
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Histological Ki67 cancer cell proliferation index
[ Time Frame: at surgery 2-6 weeks after randomisation ]

Secondary Outcome Measures:
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) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 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).
Open or close this module Contacts/Locations
Central Contact Person: Mark A Hull, PhD, FRCP
Telephone: 0113 343 8650
Email: m.a.hull@leeds.ac.uk
Central Contact Backup: Andrew J Cockbain, MBChB, MRCS
Telephone: 077935 43685
Email: a.j.cockbain@leeds.ac.uk
Study Officials: Mark A Hull, PhD, FRCP
Principal Investigator
Leeds Institute of Molecular Medicine, University of Leeds
Locations: United Kingdom, West Yorkshire
Leeds Institute of Molecular Medicine, St James's University Hospital
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Contact:Principal Investigator: Mark A Hull, PhD, FRCP
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services