Enteral Nutrition Support in Children and Adolescents With Cancer
|ClinicalTrials.gov Identifier: NCT01426750|
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : August 31, 2011
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Cancer||Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial|
|Study Start Date :||June 2002|
|Primary Completion Date :||June 2006|
|Study Completion Date :||June 2006|
Experimental: IOS, TFR
industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).
Dietary Supplement: 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.