Assessment of the Nutritional Status of Children and Adolescents With Malignancies

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246452
• Other study ID #: EM-13
• Status: Completed
• Phase: N/A
• First received: September 17, 2014
• Last updated: September 19, 2014
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	Olgahospital Stuttgart

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status at 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)	Within the month of diagnosis	No
Primary	Change in nutritional status during treatment	To assess the nutritional status height and weight were recorded from patient charts to calculate the BMI percentile and the BMI-SDS	Every month during the treatment period (average treatment period 11 months)	No
Primary	Change in nutritional status during follow-up	To assess the nutritional status height and weight were recorded from patient chart to calculate the BMI percentile and the BMI-SDS	Once in a period of three months during two years follow-up	No
Secondary	Clinical picture	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	Within the month of diagnosis	No
Secondary	Age (years)	Age in years, recorded from patient chart	Within the month of diagnosis	No
Secondary	Treatment period (months)	Time from start until the end of treatment, recorded from patient chart	Patients were followed for the duration of their treatment period. Average treatment period 11 months	No
Secondary	Incidence of nutritional interventions	Application of parenteral nutrition or gastric tube (yes/no), recorded from patient chart	Patients were followed for the incidence of a nutritional intervention within the treatment period (average treatment period 11 months)	No
Secondary	Infection	Occurence of an infection (yes/no), recorded from patient chart	Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)	No
Secondary	Fever	Occurence of fever (yes/no), recorded from patient chart	Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)	No
Secondary	Administration of antibiotics	Administration of antibiotics (yes/no), recorded from patient chart	Patients were followed for the occurence of an administration of antibiotics within the treatment period (average treatment period 11 months)	No
Secondary	Diarrhea	Occurence of diarrhea (yes/no), recorded from patient chart	Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)	No
Secondary	Mucositis	Occurence of mucositis (yes/no),recorded from patient chart	Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)	No
Secondary	Nausea	Occurence of nausea (yes/no), recorded from patient chart	Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)	No
Secondary	Constipation	Occurence of constipation (yes/no), recorded from patient chart	Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)	No
Secondary	Relapse/Progress	Occurence of a relapse/progress (yes/no), recorded from patient chart	Patients were followed for the occurence of a relapse/progress within the treatment period (average treatment period 11 months) and follow-up (two years)	No
Secondary	Kind of treatment	Kind of treatment (chemotherapy, operation, Radiation), recorded from Patient chart	Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)	No