The Effects of Eicosapentaenoic Acid (EPA) on Biomarkers of Growth and Vascularity in Human Colorectal Cancer Liver Metastases (The EPA for Metastasis Trial)
18 Years
N/A
Both
Colorectal Cancer
Trial Information
The Effects of Eicosapentaenoic Acid (EPA) on Biomarkers of Growth and Vascularity in Human Colorectal Cancer Liver Metastases (The EPA for Metastasis Trial)
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.
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).
Type of Study:
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
Outcome Measure:
Histological Ki67 cancer cell proliferation index
Outcome Time Frame:
at surgery 2-6 weeks after randomisation
Safety Issue:
No
Principal Investigator
Mark A Hull, PhD, FRCP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Leeds Institute of Molecular Medicine, University of Leeds
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
GA09/9094
NCT ID:
NCT01070355
Start Date:
April 2010
Completion Date:
October 2011
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
- Fish Oils
- Fatty Acids, Omega-3
- Eicosapentaenoic Acid
- Liver Metastases
- Randomised Controlled Trial
- Colorectal Neoplasms
- Neoplasm Metastasis
- Liver Neoplasms
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