Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-25 @ 7:06 PM
Study NCT ID:
NCT00942292
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
2009-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Fish Oils on Human Hepatic Colorectal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-24', 'studyFirstSubmitDate': '2009-07-16', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': "Changes in biomarkers of inflammation and angiogenesis in the patient's blood and resected tumour samples", 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatic', 'colorectal', 'metastases', 'TPN', 'Fish oil'], 'conditions': ['Colorectal Liver Metastases']}, 'referencesModule': {'references': [{'pmid': '8843174', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9323693', 'type': 'BACKGROUND', 'citation': 'Roulet M, Frascarolo P, Pilet M, Chapuis G. Effects of intravenously infused fish oil on platelet fatty acid phospholipid composition and on platelet function in postoperative trauma. JPEN J Parenter Enteral Nutr. 1997 Sep-Oct;21(5):296-301. doi: 10.1177/0148607197021005296.'}, {'pmid': '11895146', 'type': 'BACKGROUND', 'citation': 'Schauder P, Rohn U, Schafer G, Korff G, Schenk HD. Impact of fish oil enriched total parenteral nutrition on DNA synthesis, cytokine release and receptor expression by lymphocytes in the postoperative period. Br J Nutr. 2002 Jan;87 Suppl 1:S103-10. doi: 10.1079/bjn2001463.'}, {'pmid': '12897994', 'type': 'BACKGROUND', 'citation': 'Mayer K, Fegbeutel C, Hattar K, Sibelius U, Kramer HJ, Heuer KU, Temmesfeld-Wollbruck B, Gokorsch S, Grimminger F, Seeger W. Omega-3 vs. omega-6 lipid emulsions exert differential influence on neutrophils in septic shock patients: impact on plasma fatty acids and lipid mediator generation. Intensive Care Med. 2003 Sep;29(9):1472-81. doi: 10.1007/s00134-003-1900-2. Epub 2003 Jul 25.'}, {'pmid': '12615625', 'type': 'BACKGROUND', 'citation': 'Mayer K, Gokorsch S, Fegbeutel C, Hattar K, Rosseau S, Walmrath D, Seeger W, Grimminger F. Parenteral nutrition with fish oil modulates cytokine response in patients with sepsis. Am J Respir Crit Care Med. 2003 May 15;167(10):1321-8. doi: 10.1164/rccm.200207-674OC. Epub 2003 Feb 25.'}, {'type': 'BACKGROUND', 'citation': 'Schulzki, C., et al., Effect of a new type of lipid emulsion base on soybean oil, MCT, olive oil and fish oil (SMOF) in surgical patients. Clinical Nutrition, 1999. 19(Supp 1): p. S7.'}, {'pmid': '11895158', 'type': 'BACKGROUND', 'citation': 'Weiss G, Meyer F, Matthies B, Pross M, Koenig W, Lippert H. Immunomodulation by perioperative administration of n-3 fatty acids. Br J Nutr. 2002 Jan;87 Suppl 1:S89-94. doi: 10.1079/bjn2001461.'}, {'type': 'BACKGROUND', 'citation': "Grimminger, F., W. Seeger, and K. Mayer, Use of omeg-3 fatty acid-containing lipid emulsions in the intensive care unit environment: the clinician's view. Clinical Nutrition, 2002. 21(2): p. 23-9."}, {'type': 'BACKGROUND', 'citation': 'Grimble, R., et al., Effects of fish oil supplementation on ability of monocytes to invoke a pro-inflammatory response in endothelial cells. Clinical Nutrition, 2004. 23(4): p. 833-834.'}, {'type': 'BACKGROUND', 'citation': 'Morlion, B., et al., What is the optimum omega-3 to omega-6 fatty acid (FA) ratio of patenteral lipid emulsions in post-operative trauma? Clinical Nutrition, 1997. 16(Suppl 2): p. 49.'}, {'pmid': '10700528', 'type': 'BACKGROUND', 'citation': 'Furst P, Kuhn KS. Fish oil emulsions: what benefits can they bring? Clin Nutr. 2000 Feb;19(1):7-14. doi: 10.1054/clnu.1999.0072. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Adolph, M., Lipid emulsions in parenteral nutrition - state of the art and future perspectives. Clinical Nutrition, 2001. 20(Suppl 4): p. 1'}, {'pmid': '7815672', 'type': 'BACKGROUND', 'citation': 'Grimm H, Tibell A, Norrlind B, Blecher C, Wilker S, Schwemmle K. Immunoregulation by parenteral lipids: impact of the n-3 to n-6 fatty acid ratio. 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Dupertuis, and C. Pichard, Influence of polyunsaturated fatty acids on the growth and radio-sensitivity of three human colorectal adenocarcinoma cell lines. Clinical Nutrition, 2004. 23(4): p. 801'}, {'type': 'BACKGROUND', 'citation': 'Sturlan, S., et al., Long-chain omega-3 polyunsaturated fatty acids enhance arsenic trioxide cytotoxicity in breast cancer cells. Clinical Nutrition, 2004. 23(4): p. 797'}, {'pmid': '11895160', 'type': 'BACKGROUND', 'citation': 'Heller AR, Fischer S, Rossel T, Geiger S, Siegert G, Ragaller M, Zimmermann T, Koch T. Impact of n-3 fatty acid supplemented parenteral nutrition on haemostasis patterns after major abdominal surgery. Br J Nutr. 2002 Jan;87 Suppl 1:S95-101. doi: 10.1079/bjn2001462.'}, {'pmid': '8875517', 'type': 'BACKGROUND', 'citation': 'Katz DP, Manner T, Furst P, Askanazi J. The use of an intravenous fish oil emulsion enriched with omega-3 fatty acids in patients with cystic fibrosis. 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Liver function and plasma antioxidant status in intensive care unit patients requiring total parenteral nutrition: comparison of 2 fat emulsions. JPEN J Parenter Enteral Nutr. 2004 May-Jun;28(3):142-8. doi: 10.1177/0148607104028003142.'}, {'pmid': '14568963', 'type': 'BACKGROUND', 'citation': 'Mayer K, Meyer S, Reinholz-Muhly M, Maus U, Merfels M, Lohmeyer J, Grimminger F, Seeger W. Short-time infusion of fish oil-based lipid emulsions, approved for parenteral nutrition, reduces monocyte proinflammatory cytokine generation and adhesive interaction with endothelium in humans. J Immunol. 2003 Nov 1;171(9):4837-43. doi: 10.4049/jimmunol.171.9.4837.'}, {'type': 'BACKGROUND', 'citation': 'Schlotzer, E., et al., Intravenous application of a fish oil emulsion. Akt Ernahr Med, 1992. 17: p. 170-5.'}, {'type': 'BACKGROUND', 'citation': 'Richelle, M., et al., Does fish oil supplementation effect the intravascular effect of LCT emulsion in man. 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Evaluation of chemotherapy in advanced urinary bladder cancer with fast dynamic contrast-enhanced MR imaging. Radiology. 1998 Jun;207(3):791-7. doi: 10.1148/radiology.207.3.9609906.'}, {'pmid': '14517187', 'type': 'BACKGROUND', 'citation': "Morgan B, Thomas AL, Drevs J, Hennig J, Buchert M, Jivan A, Horsfield MA, Mross K, Ball HA, Lee L, Mietlowski W, Fuxuis S, Unger C, O'Byrne K, Henry A, Cherryman GR, Laurent D, Dugan M, Marme D, Steward WP. Dynamic contrast-enhanced magnetic resonance imaging as a biomarker for the pharmacological response of PTK787/ZK 222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases, in patients with advanced colorectal cancer and liver metastases: results from two phase I studies. J Clin Oncol. 2003 Nov 1;21(21):3955-64. doi: 10.1200/JCO.2003.08.092. Epub 2003 Sep 29."}, {'pmid': '12711251', 'type': 'BACKGROUND', 'citation': 'Tsuji M, Murota SI, Morita I. Docosapentaenoic acid (22:5, n-3) suppressed tube-forming activity in endothelial cells induced by vascular endothelial growth factor. Prostaglandins Leukot Essent Fatty Acids. 2003 May;68(5):337-42. doi: 10.1016/s0952-3278(03)00025-5.'}, {'pmid': '23648075', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'Fish oils have many proven benefits for a wide range of clinical arenas such as ischaemic heart disease, rheumatoid arthritis and inflammatory bowel disease.\n\nRecent 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.\n\nThere 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\n\n1. Fish oils inhibit the growth of different human cancer cell lines\n2. They act specifically on tumour cells only and do not impair the function of normal cells\n3. EPA and DHA inhibit the growth of human cancer cell lines and enhance apoptosis.\n4. Fish oil induces apoptosis in human colorectal cancer cell lines in-vitro after 48hrs incubation\n5. Fish oil has been shown to inhibit the proliferation activities, inhibit the invasive activities and increase the apoptosis of human pancreatic carcinoma cell lines in-vitro after only 48hrs of exposure\n6. Fish oil has been shown to enhance colorectal adenocarcinoma cell lines sensitivity to radiotherapy\n7. Fish oil has also been shown to reduce the incidence of liver metastases in experimentally induced ductal pancreatic cancer in rats after 30 weeks of oral treatment with an omega-3 supplemented diet.\n8. Lung cancer xenografts in animals fed with fish oil showed significantly increased tumour regression in response to doxorubicin compared to those fed with omega-3.\n\nThis 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.\n\nChanges 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.\n\nIt is a randomised controlled double blind trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-80\n2. Able to give informed written consent\n3. Diagnosis of respectable hepatic colorectal metastases on radiological and laparoscopic appearances\n\nExclusion Criteria:\n\n1. Patients already taking fish oil supplements\n2. Hypersensitivity to fish-, egg-, or soy protein, or to any of the active substances or constituents in the lipid emulsion\n3. Hyperlipidaemia\n4. Severe blood coagulation disorders\n5. Severe renal insufficiency (Creatinine \\>200)\n6. Any general contra-indications to infusion therapy - pulmonary oedema, hyperhydration, decompensated cardiac insufficiency\n7. Any unstable medical conditions - uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis\n8. Patients undergoing conventional neo-adjuvant chemotherapy.'}, 'identificationModule': {'nctId': 'NCT00942292', 'briefTitle': 'The Effect of Fish Oils on Human Hepatic Colorectal Metastases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals, Leicester'}, 'officialTitle': 'Randomised Controlled Trial of the Effects of Fish Oil Emulsion in Total Parenteral Nutrition Upon Tumour Vascularity in Patients With Hepatic Colorectal Metastases', 'orgStudyIdInfo': {'id': '10097'}, 'secondaryIdInfos': [{'id': 'REC reference: 06/Q2501/160'}, {'id': 'EudraCT number: 2006-000044-71'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lipidem (fish oil)', 'description': 'Lipidem (TPN containing fish oil)', 'interventionNames': ['Dietary Supplement: Lipidem- fish oil emulsion BBraun UK', 'Procedure: Digital Contrast MRI scan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lipofundin (TPN)', 'description': 'Control arm (no fish oil)', 'interventionNames': ['Dietary Supplement: Lipidem- fish oil emulsion BBraun UK', 'Procedure: Digital Contrast MRI scan']}], 'interventions': [{'name': 'Lipidem- fish oil emulsion BBraun UK', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Lipidem (fish oil)', 'Lipofundin (TPN)']}, {'name': 'Digital Contrast MRI scan', 'type': 'PROCEDURE', 'armGroupLabels': ['Lipidem (fish oil)', 'Lipofundin (TPN)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE5 4PW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Leicester General Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Ashley R Dennison, MBChB, FRCS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leicester General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals, Leicester', 'class': 'OTHER'}, 'collaborators': [{'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}