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Enteral Nutrition Support in Children and Adolescents With Cancer

G

Grupo de Apoio ao Adolescente e a Crianca com Cancer

Status and phase

Completed
Phase 4

Conditions

Malnutrition
Cancer

Treatments

Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren

Study type

Interventional

Funder types

Other

Identifiers

NCT01426750
RPM 1463/7

Details and patient eligibility

About

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.

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 1 patient group

IOS, TFR
Experimental group
Description:
industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).
Treatment:
Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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