Assessment of the Nutritional Status of Children and Adolescents With Malignancies

NCT02246452 | Completed

• 1 other identifier: EM-13
• Study Type: observational
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition

Keywords

Children and adolescents; Cancer; Malnutrition; BMI percentile; BMI-SDS

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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

Secondary Outcomes (13)

• Clinical picture

  Within the month of diagnosis

• 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

• 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)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents, treated for one of the following diseases: lymphoma, germ cell tumor, nephroblastoma, soft tissue sarcoma, neuroblastoma, Ewing sarcoma, brain tumor, or acute lymphoblastic leukemia (ALL)/acute myeloid leukemia (AML)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hohenheim: lead
• Olgahospital Stuttgart: collaborator

MeSH Terms

Conditions

Malnutrition; Neoplasms

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 22, 2014
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-09