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Clinical Trials/NCT02246452
NCT02246452
Completed
N/A

Assessment of the Nutritional Status of Children and Adolescents With Malignancies Aged Between 0-18, Based on BMI Percentiles and Standard Deviation Scores, at Diagnosis, During Treatment, and During Two Years Follow-up

University of Hohenheim0 sites135 target enrollmentJune 2013
ConditionsMalnutrition

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malnutrition
Sponsor
University of Hohenheim
Enrollment
135
Primary Endpoint
Change in nutritional status during follow-up
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The main objective of this study was the assessment of the nutritional status of children and adolescents aged between 0-18 with malignancies based on BMI percentiles and standard deviation scores, at diagnosis, during treatment and during a period of two years after the end of therapy.

Detailed Description

Children and adolescents suffering from malignancies often show malnutrition. Malnutrition, defined as a deficiency or an excess of energy, is associated with an increased risk of comorbidities, reduced survival rates, higher relapse rates, and worse treatment response. The present retrospective study assessed the nutritional status of children and adolescents, suffering from nine different kinds of cancer, based on BMI percentiles and standard deviation scores. Anthropometric data were recorded from clinical charts and an assessment of the nutritional status was made at the beginning of treatment, during the course of therapy and during a follow-up period of two years. The influence of treatment-related characteristics, the duration of therapy, and the occurrence of a relapse or progress during therapy on the nutritional status were examined.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • children and adolescents treated at the Olgahospital Stuttgart for one of the nine different cancer types
  • treated according to a study protocol of the Society of Pediatric Oncology and Hematology (GPOH), with modifications only allowed within the therapeutic protocol
  • time period between diagnosis and start of treatment less than 28 days
  • age younger than 18

Exclusion Criteria

  • severe underlying disease, which exerts a strong influence on weight and/or height
  • patients whose clinical record does not state any weight and/or height
  • diseases which are not considered as malignant because of the state or biology

Outcomes

Primary Outcomes

Change in nutritional status during follow-up

Time Frame: Once in a period of three months during two years follow-up

To assess the nutritional status height and weight were recorded from patient chart to calculate the BMI percentile and the BMI-SDS

Nutritional status at diagnosis

Time Frame: Within the month of diagnosis

To assess the nutritional status height and weight were recorded from patient charts to calculate the BMI percentile (Body Mass Index percentile) and the BMI-SDS (Body Mass Index-Standard Deviation Score)

Change in nutritional status during treatment

Time Frame: Every month during the treatment period (average treatment period 11 months)

To assess the nutritional status height and weight were recorded from patient charts to calculate the BMI percentile and the BMI-SDS

Secondary Outcomes

  • Constipation(Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months))
  • Kind of treatment(Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months))
  • Age (years)(Within the month of diagnosis)
  • Treatment period (months)(Patients were followed for the duration of their treatment period. Average treatment period 11 months)
  • Fever(Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months))
  • Mucositis(Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months))
  • Incidence of nutritional interventions(Patients were followed for the incidence of a nutritional intervention within the treatment period (average treatment period 11 months))
  • Infection(Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months))
  • Administration of antibiotics(Patients were followed for the occurence of an administration of antibiotics within the treatment period (average treatment period 11 months))
  • Diarrhea(Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months))
  • Relapse/Progress(Patients were followed for the occurence of a relapse/progress within the treatment period (average treatment period 11 months) and follow-up (two years))
  • Clinical picture(Within the month of diagnosis)
  • Nausea(Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months))

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