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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Hull, University of Leeds
ClinicalTrials.gov Identifier:
NCT01070355
First received: February 12, 2010
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Histological Ki67 cancer cell proliferation index [ Time Frame: at surgery 2-6 weeks after randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histological neo-CK18 cancer cell apoptosis index [ Time Frame: at surgery 2-6 weeks after randomisation ] [ Designated as safety issue: No ]
  • Histological tumour CD31-positive cell microvessel density [ Time Frame: at surgery 2-6 weeks after randomisation ] [ Designated as safety issue: No ]
  • Safety and tolerability of EPA treatment [ Time Frame: Every 2 weeks whilst patient is taking study medication ] [ Designated as safety issue: Yes ]
  • Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels [ Time Frame: at surgery 2-6 weeks after randomisation ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Leeds

Additional 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
Study First Received: February 12, 2010
Last Updated: October 20, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University of Leeds:
Colorectal Neoplasms
Fish Oils
Fatty Acids, Omega-3
 Eicosapentaenoic Acid
Liver Metastases
Randomised Controlled Trial

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
 Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on March 03, 2015