Enteral Nutrition Support in Children and Adolescents With Cancer
NCT ID: NCT01426750
Last Updated: 2011-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
INTERVENTIONAL
2002-06-30
2006-06-30
Brief Summary
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DESIGN 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IOS, TFR
industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).
industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren
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.
Interventions
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industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* Swallowing abnormalities
* Parenteral or tube feeding therapy
* Palliative care and presence of non cancer-related diseases.
1 Year
ALL
No
Sponsors
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Grupo de Apoio ao Adolescente e a Crianca com Cancer
OTHER
Responsible Party
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Other Identifiers
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RPM 1463/7
Identifier Type: -
Identifier Source: org_study_id