Enteral Nutrition Support in Children and Adolescents With Cancer

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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Key information

Conditions

Malnutrition Cancer Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

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.

Sponsors and collaborators

Lead sponsor

Grupo de Apoio ao Adolescente e a Crianca com Cancer

Other

Registry information

Official study title

Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial

Important dates

Study start: 2002
Primary completion: 2006
Study completion: 2006
First posted: Aug 31, 2011
Registry last updated: Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed