Clinical trial NCT02246452: Assessment of the Nutritional Status of Children and Adolescents With Malignancies
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: Children and adolescents
Cancer
Malnutrition
BMI percentile
BMI-SDS
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: Olgahospital Stuttgart
First posted: 2014-09-22
Enrollment: 135
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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)

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.

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

Primary outcomes:
measure: Nutritional status at diagnosis
timeFrame: Within the month of diagnosis
measure: Change in nutritional status during treatment
timeFrame: Every month during the treatment period (average treatment period 11 months)
measure: Change in nutritional status during follow-up
timeFrame: Once in a period of three months during two years follow-up
Secondary outcomes:
measure: Clinical picture
timeFrame: Within the month of diagnosis
measure: Age (years)
timeFrame: Within the month of diagnosis
measure: Treatment period (months)
timeFrame: Patients were followed for the duration of their treatment period. Average treatment period 11 months
measure: Incidence of nutritional interventions
timeFrame: Patients were followed for the incidence of a nutritional intervention within the treatment period (average treatment period 11 months)
measure: Infection
timeFrame: Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)
measure: Fever
timeFrame: Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)
measure: Administration of antibiotics
timeFrame: Patients were followed for the occurence of an administration of antibiotics within the treatment period (average treatment period 11 months)
measure: Diarrhea
timeFrame: Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)
measure: Mucositis
timeFrame: Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)
measure: Nausea
timeFrame: Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)
measure: Constipation
timeFrame: Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)
measure: Relapse/Progress
timeFrame: Patients were followed for the occurence of a relapse/progress within the treatment period (average treatment period 11 months) and follow-up (two years)
measure: Kind of treatment
timeFrame: Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)
Other outcomes:
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