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

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
2 capsules twice daily
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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)
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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 |
- Histological Ki67 cancer cell proliferation index [ Time Frame: at surgery 2-6 weeks after randomisation ]
- Histological neo-CK18 cancer cell apoptosis index [ Time Frame: at surgery 2-6 weeks after randomisation ]
- Histological tumour CD31-positive cell microvessel density [ Time Frame: at surgery 2-6 weeks after randomisation ]
- Safety and tolerability of EPA treatment [ Time Frame: Every 2 weeks whilst patient is taking study medication ]
- Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels [ Time Frame: at surgery 2-6 weeks after randomisation ]
- 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) ]
- 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) ]
- 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) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
United Kingdom | |
Leeds Institute of Molecular Medicine, St James's University Hospital | |
Leeds, West Yorkshire, United Kingdom, LS9 7TF |
Principal Investigator: | Mark A Hull, PhD, FRCP | Leeds Institute of Molecular Medicine, University of Leeds |
Responsible Party: | Mark Hull, Professor, University of Leeds |
ClinicalTrials.gov Identifier: | NCT01070355 |
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 |
Colorectal Neoplasms Fish Oils Fatty Acids, Omega-3 |
Eicosapentaenoic Acid Liver Metastases Randomised Controlled Trial |
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 |