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Enteral Nutrition Support in Children and Adolescents With Cancer

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ClinicalTrials.gov Identifier: NCT01426750
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : August 31, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Malnutrition Cancer Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial
Study Start Date : June 2002
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: IOS, TFR
industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).
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.

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
More Information

Responsible Party: Grupo de Apoio ao Adolescente e a Crianca com Cancer
ClinicalTrials.gov Identifier: NCT01426750     History of Changes
Other Study ID Numbers: RPM 1463/7
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: August 31, 2011
Last Verified: August 2011

Keywords provided by Grupo de Apoio ao Adolescente e a Crianca com Cancer:
Nutritional support.

Additional relevant MeSH terms:
Nutrition Disorders