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Enteral Nutrition in Cancer Patient

This study has been completed.
Sponsor:
Information provided by:
Grupo de Apoio ao Adolescente e a Crianca com Cancer
ClinicalTrials.gov Identifier:
NCT01302509
First received: October 30, 2008
Last updated: February 22, 2011
Last verified: February 2011
History of Changes

October 30, 2008
February 22, 2011
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Complete list of historical versions of study NCT01302509 on ClinicalTrials.gov Archive Site
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Enteral Nutrition in Cancer Patient
Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial.

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.
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Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malnutrition
  • Cancer
  • Pediatric
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.
Active Comparator: IOS, TFR
industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).
Intervention: Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Were chemotherapy, age above one year and malnutrition. 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 adolescents27 were considered as mild malnutrition; and 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:

  • Were corticosteroid or hormonal therapy, swallowing abnormalities, parenteral or tube feeding therapy, palliative care and presence of non cancer-related diseases.
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01302509
1968
Yes
Adriana Garófolo, Nutrition Coordinator
Grupo de Apoio ao Adolescente e a Crianca com Cancer
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Grupo de Apoio ao Adolescente e a Crianca com Cancer
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP