Enteral Nutrition Support in Children and Adolescents With Cancer

Phase 4

Completed

• Conditions: Malnutrition; Cancer
• Interventions: Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren

• Registration Number: NCT01426750
• Lead Sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2008-03-28
• Status Verified: 2011-08
• Study First Submitted QC: 2011-08-29
• Last Update Submitted: 2011-08-29
• Study First Posted: 2011-08-31
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 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

• Were corticosteroid or hormonal therapy
• Swallowing abnormalities
• Parenteral or tube feeding therapy
• Palliative care and presence of non cancer-related diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IOS, TFR	industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren	industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).