NCT01070355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 21, 2011

Status Verified

October 1, 2011

Enrollment Period

1.5 years

First QC Date

February 12, 2010

Last Update Submit

October 20, 2011

Conditions

Colorectal Cancer

Keywords

Colorectal NeoplasmsFish OilsFatty Acids, Omega-3Eicosapentaenoic AcidLiver MetastasesRandomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Histological Ki67 cancer cell proliferation index

    at surgery 2-6 weeks after randomisation

Secondary Outcomes (7)

  • Histological neo-CK18 cancer cell apoptosis index

    at surgery 2-6 weeks after randomisation

  • 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

  • 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)

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 capsules twice daily

Drug: Placebo

Eicosapentaenoic acid free fatty acid

ACTIVE COMPARATOR

2g daily (2 x 500mg capsules twice daily)

Drug: Eicosapentaenoic acid free fatty acid

Interventions

Eicosapentaenoic acid free fatty acidDRUG

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.

Also known as: ALFA
Eicosapentaenoic acid free fatty acid
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Institute of Molecular Medicine, St James's University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Related Publications (1)

  • Cockbain AJ, Volpato M, Race AD, Munarini A, Fazio C, Belluzzi A, Loadman PM, Toogood GJ, Hull MA. Anticolorectal cancer activity of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid. Gut. 2014 Nov;63(11):1760-8. doi: 10.1136/gutjnl-2013-306445. Epub 2014 Jan 27.

    PMID: 24470281DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Mark A Hull, PhD, FRCP

    Leeds Institute of Molecular Medicine, University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 18, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 21, 2011

Record last verified: 2011-10

Locations

GB(1)