Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases (EMT)
This study has been completed.
Sponsor:
University of Leeds
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
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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:
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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01070355
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
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 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 |
ClinicalTrials.gov processed this record on September 26, 2016