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 patients 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 scanners 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
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
-
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.
-
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.