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| [ ...Back to search results ] | [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | Randomised controlled trial of the effects of fish oil emulsion in total parenteral nutrition upon tumour vascularity in patients with hepatic colorectal metastases |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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. |
| Lay summary | |
| Ethics approval | No ethics approval as of 31/07/2006. |
| Study design | Randomised, double-blind, controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Hepatic colorectal metastases |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/03/2006 |
| Anticipated end date | 01/08/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 20 |
| Interventions | Intravenous feeding for three days either with or without (control) supplementation with 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. |
| 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 patient’s white blood cells (an enzyme which inhibits cancer cell death) 5. Omega-3/omega-6 ratios in subjects’ platelets and resected tumour |
| Sources of funding | BBraun Melsungen AC (Germany) |
| Trial website | |
| Publications | |
| Contact name | Mr Ashley Dennison |
| Address |
Department of Surgery
Leicester General Hospital Gwendolen Road |
| City/town | Leicester |
| Zip/Postcode | LE5 4PW |
| Country | United Kingdom |
| Tel | +44 (0)116 249 0490 |
| Fax | +44 (0)116 258 4708 |
| ashley.dennison@dial.pipex.com | |
| Sponsor | University Hospitals of Leicester NHS trust (UK) |
| Address |
University Hospitals of Leicester Trust Headquarters
Gwendolen House Gwendolen Road |
| City/town | Leicester |
| Zip/Postcode | LE5 4PW |
| Country | United Kingdom |
| Date applied | 17/01/2006 |
| Last edited | 20/01/2011 |
| Date ISRCTN assigned | 31/07/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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