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

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ClinicalTrials.gov Identifier: NCT01070355
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : October 21, 2011
Sponsor:
Information provided by (Responsible Party):
Mark Hull, University of Leeds

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Eicosapentaenoic acid free fatty acid Drug: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
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)
Study Start Date : April 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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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) ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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 Posted: February 18, 2010    Key Record Dates
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