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

Colorectal Cancer Clinical Trial

— EMT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070355
• Other study ID #: GA09/9094
• Secondary ID: 2009-015903-22
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2010
• Last updated: October 20, 2011
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• Placebo
2 capsules taken twice daily for 2-6 weeks before liver resection.

Locations

Country	Name	City	State
United Kingdom	Leeds Institute of Molecular Medicine, St James's University Hospital	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological Ki67 cancer cell proliferation index		at surgery 2-6 weeks after randomisation	No
Secondary	Histological neo-CK18 cancer cell apoptosis index		at surgery 2-6 weeks after randomisation	No
Secondary	Histological tumour CD31-positive cell microvessel density		at surgery 2-6 weeks after randomisation	No
Secondary	Safety and tolerability of EPA treatment		Every 2 weeks whilst patient is taking study medication	Yes
Secondary	Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels		at surgery 2-6 weeks after randomisation	No
Secondary	Plasma markers of prostaglandin metabolism		1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)	No
Secondary	Platelet aggregation		1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)	Yes
Secondary	Urinary markers of prostaglandin metabolism		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)	No