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 |
| EudraCT/CTIS number | 2006-000044-71 |
| ClinicalTrials.gov number | NCT00942292 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Surgery
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
| Phone | +44 (0)116 249 0490 |
|---|---|
| ashley.dennison@dial.pipex.com |
Study information
| Study design | Randomised, double-blind, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Omega-3 fatty acids |
| Primary outcome measure | 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 study start date | 01/03/2006 |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Surgery
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS trust (UK)
Hospital/treatment centre
Hospital/treatment centre
University Hospitals of Leicester Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
"ROR" |
https://ror.org/02fha3693 |
|---|
Funders
Funder type
Industry
BBraun Melsungen AC (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
