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

University of Leeds

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Eicosapentaenoic acid free fatty acid

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01070355

2009-015903-22 (EudraCT Number)

GA09/9094

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).