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Enteral Nutrition Support in Children and Adolescents With Cancer

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01426750
Enrollment
Unknown
Registered
2011-08-31
Start date
2002-06-30
Completion date
2006-06-30
Last updated
2011-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Malnutrition

Keywords

Nutritional support., Cancer., Malnutrition., Child., Adolescent

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.

Interventions

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

Grupo de Apoio ao Adolescente e a Crianca com Cancer
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026