Assessment of the Nutritional Status of Children and Adolescents With Malignancies

Completed

• Conditions: Malnutrition

• Registration Number: NCT02246452
• Lead Sponsor: University of Hohenheim

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.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-19
• Last Update Submitted: 2014-09-19
• Study First Posted: 2014-09-22
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in nutritional status during follow-up	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	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	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 Outcome Measures

Name	Time	Method
Constipation	Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)	Occurence of constipation (yes/no), recorded from patient chart
Kind of treatment	Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)	Kind of treatment (chemotherapy, operation, Radiation), recorded from Patient chart
Age (years)	Within the month of diagnosis	Age in years, recorded from patient chart
Treatment period (months)	Patients were followed for the duration of their treatment period. Average treatment period 11 months	Time from start until the end of treatment, recorded from patient chart
Fever	Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)	Occurence of fever (yes/no), recorded from patient chart
Mucositis	Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)	Occurence of mucositis (yes/no),recorded from patient chart
Incidence of nutritional interventions	Patients were followed for the incidence of a nutritional intervention within the treatment period (average treatment period 11 months)	Application of parenteral nutrition or gastric tube (yes/no), recorded from patient chart
Infection	Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)	Occurence of an infection (yes/no), recorded from patient chart
Administration of antibiotics	Patients were followed for the occurence of an administration of antibiotics within the treatment period (average treatment period 11 months)	Administration of antibiotics (yes/no), recorded from patient chart
Diarrhea	Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)	Occurence of diarrhea (yes/no), recorded from patient chart
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)	Occurence of a relapse/progress (yes/no), recorded from patient chart
Clinical picture	Within the month of diagnosis	Kind of cancer (lymphoma, germ cell tumor, nephroblastoma, soft tissue sarcoma, neuroblastoma, Ewing sarcoma, brain tumor, acute lymphoblastic leukemia (ALL)/acute myeloid leukemia (AML)), recorded from patient chart
Nausea	Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)	Occurence of nausea (yes/no), recorded from patient chart