Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-03-09 @ 4:10 AM
Study NCT ID:
NCT02626195
Status:
COMPLETED
Last Update Posted:
2018-06-11
First Post:
2015-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Nutritional Support in Malnutritional Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-12-07', 'lastUpdatePostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'immunologic change(CD4/CD8) after nutritional support', 'timeFrame': 'preoperative, postoperative 14days', 'description': 'CD4/CD8, immunoglobulin G, M, A'}], 'primaryOutcomes': [{'measure': 'postoperative complication', 'timeFrame': 'at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)', 'description': 'expected the duration of hospital stay of postoperation is 4\\~6 weeks.'}], 'secondaryOutcomes': [{'measure': 'postoperative hospital stay', 'timeFrame': 'expected the duration of hospital stay of postoperation is 4~6 weeks.', 'description': 'expected the duration of hospital stay of postoperation is 4\\~6 weeks.'}, {'measure': 'quality of life', 'timeFrame': 'preoperative, postoperative 14days', 'description': 'preoperative, postoperative 14days'}, {'measure': 'postoperative cost( + nutritional support cost)', 'timeFrame': 'at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)', 'description': 'expected the duration of hospital stay of postoperation is 4\\~6 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malnutrition', 'nutrition', 'nutritional support', 'hepatobiliary pancreatic cancer', 'hepatobiliary pancreatic surgery'], 'conditions': ['Pancreatic Cancer', 'Biliary Cancer', 'Malnutrition']}, 'descriptionModule': {'briefSummary': 'Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients.\n\nThe purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.', 'detailedDescription': 'This is single arm study with historical comparison. The historical control group did not receiving nutritional support. In previous results show that about 25% complication rates. Complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (NCCNCS-11-460)).\n\nFor support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. Nutritional support program is briefly described below.\n\nInterval: 5-10 days Contents: admission is required\n\n* Calories: 30-35Kg, via enteral or parenteral\n* Protein: 1.2-1.5g/Kg\n* Lipid : 1-1.5g/Kg\n* Mineral and vitamins supply\n* Blood glucose control\n* Daily monitoring by dietician and specialized nurse'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects in anticipating major surgery of hepatobiliary pancreatic cancer\n2. Patients diagnosed with malnutrition (at least more than one)\n\n 1. PG-SGA B or C\n 2. Weight loss \\>10% within 6 month\n 3. BMI \\<18.5\n 4. Serum Albumin \\<3.0\n3. Age less than 80 years old over 20 years old\n4. Performance status (ECOG scale): 0-1\n5. Adequate organ functions\n\n 1. Hb ≥7.0 g/dl\n 2. ANC ≥1,500/mm3\n 3. PLT ≥80,000/mm3\n 4. Liver function: AST/ALT ≤5×upper limit of normal\n 5. Creatinine ≤2.0 ULN\n\nExclusion Criteria:\n\n1. Biopsy, drainage tube insertion, and other minor surgery\n2. palliative surgery\n3. Serious illness or medical conditions, as follows;\n\n 1. congestive heart failure (NYHA class III or IV)\n 2. unstable angina or myocardial infarction within the past 6 months,\n 3. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block\n 4. uncontrolled hypertension\n 5. hepatic cirrhosis( ≥ Child class B)\n 6. interstitial pneumonia, pulmonary adenomatosis\n 7. psychiatric disorder that may interfere with and/or protocol compliance\n 8. unstable diabetes mellitus\n 9. uncontrolled ascites or pleural effusion\n 10. active infection\n4. Pregnancy\n5. Any patients judged by the investigator to be unfit to participate in the study'}, 'identificationModule': {'nctId': 'NCT02626195', 'briefTitle': 'Preoperative Nutritional Support in Malnutritional Cancer Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients', 'orgStudyIdInfo': {'id': 'NCCCTS-13-676'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nutritional support program apply', 'description': 'Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.', 'interventionNames': ['Dietary Supplement: nutritional support program']}, {'type': 'NO_INTERVENTION', 'label': 'historical control group', 'description': 'Historical control group is that did not receiving'}], 'interventions': [{'name': 'nutritional support program', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutritional support program is briefly described below.\n\nInterval: 5-10 days Contents: admission is required\n\n* Calories: 30-35Kg, via enteral or parenteral\n* Protein: 1.2-1.5g/Kg\n* Lipid : 1-1.5g/Kg\n* Mineral and vitamins supply\n* Blood glucose control\n* Daily monitoring by dietician and specialized nurse', 'armGroupLabels': ['nutritional support program apply']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'SangJae Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch', 'investigatorFullName': 'Sang-Jae Park', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}