Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/01/2006
Date assigned
31/07/2006
Last edited
18/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ashley Dennison

ORCID ID

Contact details

Department of Surgery
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 249 0490
ashley.dennison@dial.pipex.com

Additional identifiers

EudraCT number

2006-000044-71

ClinicalTrials.gov number

NCT00942292

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The hypothesis is that intravenous feeding supplemented with omega-3 fatty acids will reduce the tumour vascularity as assessed by dynamic contrast-enhanced Magnetic Resonance Imaging (MRI) in patients with hepatic colorectal metastases.

Ethics approval

No ethics approval as of 31/07/2006.

Study design

Randomised, double-blind, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hepatic colorectal metastases

Intervention

Intravenous feeding for three days either with or without (control) supplementation with omega-3 fatty acids.

Intervention type

Drug

Phase

Not Specified

Drug names

Omega-3 fatty acids

Primary outcome measures

To assess the effect of intravenous feeding supplemented with omega-3 fatty acids on tumour vascularity as assessed by dynamic contrast enhanced MRI.

Secondary outcome measures

1. Changes in serum levels of leukotrienes B5 and B4, Tumor Necrosis Factor alpha (TNF-a) and Interleukin 6 (IL-6). These are modulators of the inflammatory response
2. Measurements of omega-3 fatty acid levels and ratios in cellular membranes of blood leukocytes (white blood cells)
3. Change in vascular endothelial growth factor receptor levels
4. Changes in Cyclooxygenase-2 (COX-2) activity in patient’s white blood cells (an enzyme which inhibits cancer cell death)
5. Omega-3/omega-6 ratios in subjects’ platelets and resected tumour

Overall trial start date

01/03/2006

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with hepatic colorectal metastases, in whom the disease is assessed as amenable to curative resection will be eligible for the study. The inclusion criteria will be:
1. Ages 18-80
2. Able to give informed written consent
3. Diagnosis of resectable hepatic colorectal metastases on radiological and laparoscopic appearance (this trial is only assessing operative disease)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Patients will be excluded from this trial if they have:
1. Malignant disease that is not thought to be potentially operable after laparoscopy
2. Patients already taking fish oil supplements (may interfere with results)
3. Patients already enrolled into other trials (e.g. of chemotherapy)
4. Hypersensitivity to fish, egg or soy protein or to any of the active substances or constituents in the lipid emulsion
5. Hyperlipidaemia
6. Severe blood coagulation disorders
7. Severe renal insufficiency (creatinine >200)
8. Any general contra-indications to infusion therapy – pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
9. Any unstable medical conditions – uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis

Patients meeting the above criteria are excluded as they represent inoperable disease, cases where the results would be invalid (already taking fish oil supplements), contraindications to lipid infusion and unstable medical conditions.

Patients will also be excluded if they have any contraindications to MRI scanning:
1. Cardiac pacemaker
2. Other ferromagnetic metal implants not authorised for use in MRI such as certain types of cerebral aneurysm clips
3. Claustrophobia
4. Body weight or circumference beyond the MRI scanner’s capacity

Recruitment start date

01/03/2006

Recruitment end date

01/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Surgery
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS trust (UK)

Sponsor details

University Hospitals of Leicester Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

BBraun Melsungen AC (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23648075
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23647811

Publication citations

  1. Results

    Al-Taan O, Stephenson JA, Spencer L, Pollard C, West AL, Calder PC, Metcalfe M, Dennison AR, Changes in plasma and erythrocyte omega-6 and omega-3 fatty acids in response to intravenous supply of omega-3 fatty acids in patients with hepatic colorectal metastases., Lipids Health Dis, 2013, 12, 64, doi: 10.1186/1476-511X-12-64.

  2. Results

    Stephenson JA, Al-Taan O, Arshad A, West AL, Calder PC, Morgan B, Metcalfe MS, Dennison AR, Unsaturated fatty acids differ between hepatic colorectal metastases and liver tissue without tumour in humans: results from a randomised controlled trial of intravenous eicosapentaenoic and docosahexaenoic acids., Prostaglandins Leukot. Essent. Fatty Acids, 2013, 88, 6, 405-410, doi: 10.1016/j.plefa.2013.04.002.

Additional files

Editorial Notes