Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-02 @ 11:19 AM
Study NCT ID:
NCT00945568
Status:
COMPLETED
Last Update Posted:
2009-07-24
First Post:
2009-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Oral Supplementation With Branched-Chain Amino Acids (BCAA) Improves Postoperative Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-07-10', 'releaseDate': '2012-06-06'}], 'estimatedResultsFirstSubmitDate': '2012-06-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-23', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery.', 'timeFrame': '3-6 months'}], 'secondaryOutcomes': [{'measure': 'To investigate the safety, rationality and postoperative QOL in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for HCC with chronic liver disease.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['QOL', 'liver'], 'conditions': ['Hepatocellular Carcinoma', 'Chronic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '20852905', 'type': 'DERIVED', 'citation': 'Okabayashi T, Iyoki M, Sugimoto T, Kobayashi M, Hanazaki K. Oral supplementation with carbohydrate- and branched-chain amino acid-enriched nutrients improves postoperative quality of life in patients undergoing hepatic resection. Amino Acids. 2011 Apr;40(4):1213-20. doi: 10.1007/s00726-010-0748-3. Epub 2010 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'The aims of this study are (1) to study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery, and (2) To investigate the postoperative quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for hepatocellular carcinoma (HCC) with chronic liver disease.', 'detailedDescription': 'Patients with cirrhosis of the liver complicated with HCC are often in a state of protein energy malnutrition. A limited number of studies have indicated an important role for nutritional support in the surgical management of patients who have undergone hepatic resection for HCC. In a preliminary study, we reported the clinical efficacy of supplementation with branched-chain amino acids in a small number of patients with liver cirrhosis who underwent hepatic surgery for HCC. The aims of this study are (1) to study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery, and (2) To investigate the postoperative QOL in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for HCC with chronic liver disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent elective liver resection for the treatment of hepatocellular carcinoma or adenocarcinoma with chronic liver diseases.\n\nExclusion Criteria:\n\n* Body weight loss greater than 10 per cent during the 6 months prior to surgery,\n* The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.'}, 'identificationModule': {'nctId': 'NCT00945568', 'acronym': 'KMS', 'briefTitle': 'Preoperative Oral Supplementation With Branched-Chain Amino Acids (BCAA) Improves Postoperative Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Kochi University'}, 'officialTitle': 'Preoperative Oral Supplementation With Carbohydrate and Branched-chain Amino Acid-enriched Nutrient Improves Postoperative Quality of Life in Patients Undergoing a Hepatectomy', 'orgStudyIdInfo': {'id': 'AEN-0901'}, 'secondaryIdInfos': [{'id': 'KMS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aminolaban EN', 'description': 'Aminoleban EN™ was administered at a dose of 100 g per day commencing two weeks prior to surgery. A 100 g dose of Aminoleban EN™ contains 13.0 g of free amino acids, 13.0 g of gelatin hydrolysate, 1.0 g of casein, 62.1 g of carbohydrate, 7.0 g of lipid, glycyrrhizin, and other components, producing 420 kcal. The AEN group included 40 patients who were administered 100 g of Aminoleban EN™ as 50 g during the day and 50 g as a late evening snack.', 'interventionNames': ['Drug: Aminoleban EN']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The patients were divided into two groups including one group administered Aminoleban (the AEN group) and a control group given no additional dietary supplementation. The total caloric energy intake per day during the study period was assumed to be equal to Aminolaban EN group.', 'interventionNames': ['Drug: Aminoleban EN']}], 'interventions': [{'name': 'Aminoleban EN', 'type': 'DRUG', 'otherNames': ['AEN'], 'description': 'benefits of this drug for patients who undergoing liver resection for HCC', 'armGroupLabels': ['Aminolaban EN', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '783-8505', 'city': 'Nankoku', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Medical School', 'geoPoint': {'lat': 33.56943, 'lon': 133.64937}}, {'zip': '783-8505', 'city': 'Nankoku', 'state': 'Kohasu-Okocho', 'country': 'Japan', 'facility': 'Kochi Medical School, Kochi University', 'geoPoint': {'lat': 33.56943, 'lon': 133.64937}}], 'overallOfficials': [{'name': 'Kazuhiro Hanazaki, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kochi University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kochi University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kochi Medical School', 'oldOrganization': 'Kochi University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-06-06', 'type': 'RELEASE'}, {'date': '2012-07-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Takehiro Okabayashi, University, Kochi University'}}}}