Colorectal Cancer
Conditions
Keywords
Colorectal Neoplasms, Fish Oils, Fatty Acids, Omega-3, Eicosapentaenoic Acid, Liver Metastases, Randomised Controlled Trial
Brief 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.
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.
Interventions
DRUGEicosapentaenoic 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.
DRUGPlacebo
2 capsules taken twice daily for 2-6 weeks before liver resection.
Sponsors
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological Ki67 cancer cell proliferation index | at surgery 2-6 weeks after randomisation |
Secondary
| Measure | Time frame |
|---|---|
| Histological tumour CD31-positive cell microvessel density | at surgery 2-6 weeks after randomisation |
| Safety and tolerability of EPA treatment | Every 2 weeks whilst patient is taking study medication |
| Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels | at surgery 2-6 weeks after randomisation |
| Histological neo-CK18 cancer cell apoptosis index | at surgery 2-6 weeks after randomisation |
| 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) |
| 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) |
| 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) |
Countries
United Kingdom
Outcome results
None listed