Randomised controlled trial of the effects of fish oil emulsion in total parenteral nutrition upon tumour vascularity in patients with hepatic colorectal metastases

ISRCTN	ISRCTN82923678
DOI	https://doi.org/10.1186/ISRCTN82923678
ClinicalTrials.gov (NCT)	NCT00942292
Clinical Trials Information System (CTIS)	2006-000044-71
Protocol serial number	N/A
Sponsor	University Hospitals of Leicester NHS trust (UK)
Funder	BBraun Melsungen AC (Germany)

Submission date: 17/01/2006
Registration date: 31/07/2006
Last edited: 18/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Ashley Dennison
Scientific

Department of Surgery
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Phone	+44 (0)116 249 0490
Email	ashley.dennison@dial.pipex.com

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	No ethics approval as of 31/07/2006.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Omega-3 fatty acids
Primary outcome measure(s)	To assess the effect of intravenous feeding supplemented with omega-3 fatty acids on tumour vascularity as assessed by dynamic contrast enhanced MRI.
Key secondary outcome measure(s)	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
Completion date	01/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	20
Key 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)
Key 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
Date of first enrolment	01/03/2006
Date of final enrolment	01/08/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Surgery

Leicester
LE5 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/05/2013		Yes	No
Results article	results	01/06/2013		Yes	No