Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-30 @ 7:59 PM
Study NCT ID:
NCT01426750
Status:
COMPLETED
Last Update Posted:
2011-08-31
First Post:
2008-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteral Nutrition Support in Children and Adolescents With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-29', 'studyFirstSubmitDate': '2008-03-28', 'studyFirstSubmitQcDate': '2011-08-29', 'lastUpdatePostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nutritional support.', 'Cancer.', 'Malnutrition.', 'Child.', 'Adolescent'], 'conditions': ['Malnutrition', 'Cancer']}, 'descriptionModule': {'briefSummary': 'CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. The aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status.\n\nDESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year followed during anticancer therapy were included from January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR) was indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Were chemotherapy, age above one year and malnutrition\n* A z-score of weight for height (zW/H) \\< -1.0 to -2.0 in children26 and ≥ 5th to \\< 15th of body mass index (BMI) in adolescents 27 were considered as mild malnutrition\n* A zW/H \\< -2.0 in children and \\< 5th of BMI in adolescents as severe, respectively.28 In adults, the World Health Organization (WHO)29 cut-off values were applied: \\< 18.5 mild and \\< 17 severe malnutrition.\n\nExclusion Criteria:\n\n* Were corticosteroid or hormonal therapy\n* Swallowing abnormalities\n* Parenteral or tube feeding therapy\n* Palliative care and presence of non cancer-related diseases.'}, 'identificationModule': {'nctId': 'NCT01426750', 'briefTitle': 'Enteral Nutrition Support in Children and Adolescents With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Grupo de Apoio ao Adolescente e a Crianca com Cancer'}, 'officialTitle': 'Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'RPM 1463/7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IOS, TFR', 'description': 'industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).', 'interventionNames': ['Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren']}], 'interventions': [{'name': 'industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The oral and tube supplement offered was Nutren Jr® (for patients aged 1 - 9 years) or Nutren 1.0- Nestlé Clinical Nutrition-Brazil (for those aged 10 years or over). This supplement was a whole powder formulation that presented a macro composition of 52% carbohydrates, 12% proteins and 36% lipids. Its vitamins were A, D, E, K, B complex, biotin and choline; its trace elements were iron, copper, zinc, manganese, selenium, chromium and molybdenum; its macroelements were potassium, calcium, sodium, chlorine, iodine, magnesium and phosphorus; and it contained taurine and L-carnitine presenting 1.0 kcal/ml.', 'armGroupLabels': ['IOS, TFR']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo de Apoio ao Adolescente e a Crianca com Cancer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}