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| ID | Type | Description | Link |
|---|---|---|---|
| REC reference: 06/Q2501/160 | |||
| EudraCT number: 2006-000044-71 |
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| Name | Class |
|---|---|
| B. Braun Melsungen AG | INDUSTRY |
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The purpose of this study is to determine whether fish oils - a known source of omega-3 given intravenously (via a 'drip') will help cure secondary deposits in the liver from bowel cancer.
Fish oils have many proven benefits for a wide range of clinical arenas such as ischaemic heart disease, rheumatoid arthritis and inflammatory bowel disease.
Recent research has described the beneficial effects of intravenous fish oils for surgical patients, such as reduced hospital stay, reduced re-operation rate and reduced requirements for intravenous antibiotics. These are in part due to the anti-inflammatory effects of fish oils.
There is evidence that fish oils are also effective against cancer, large population studies indicate that diets rich in omega-3 are associated with a lower incidence of cancer, and in vitro and animal studies demonstrate anti-tumour effects of fish oils
This study aims to assess the effect of omega-3 FA upon hepatic colorectal metastases in a pilot study. 20 patients will be selected for this pilot study with potentially resectable hepatic colorectal adenocarcinoma metastases. 10 patients will receive total parenteral nutrition (TPN) without fish oils (controls), 10 will receive fish oil containing lipid emulsion in their TPN.
Changes in tumour angiogenesis (increased angiogenesis is associated with a poorer prognosis in hepatic colorectal metastases) will be investigated using digital contrast enhanced MRI scanning, and markers of angiogenesis will be investigated in blood and resected tumour samples from the patients.
It is a randomised controlled double blind trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipidem (fish oil) | Active Comparator | Lipidem (TPN containing fish oil) |
|
| Lipofundin (TPN) | Active Comparator | Control arm (no fish oil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipidem- fish oil emulsion BBraun UK | Dietary Supplement |
| ||
| Digital Contrast MRI scan |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gadolinium chelate enhancement on DCE-MRI between study entry and exit, as determined by calculating the bi-directional transfer co-efficient.(Changes in tumour angiogenesis after treatment with fish oils or control TPN) | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in biomarkers of inflammation and angiogenesis in the patient's blood and resected tumour samples | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley R Dennison, MBChB, FRCS, MD | Leicester General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicester General Hospital | Leicester | Leicestershire | LE5 4PW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8843174 | Background | Morlion BJ, Torwesten E, Lessire H, Sturm G, Peskar BM, Furst P, Puchstein C. The effect of parenteral fish oil on leukocyte membrane fatty acid composition and leukotriene-synthesizing capacity in patients with postoperative trauma. Metabolism. 1996 Oct;45(10):1208-13. doi: 10.1016/s0026-0495(96)90237-1. | |
| 9323693 | Background |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Procedure |
|
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| 23648075 | Derived | 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 May 7;12:64. doi: 10.1186/1476-511X-12-64. |