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Assessment of the Nutritional Status of Children and Adolescents With Malignancies

19. september 2014 opdateret af: University of Hohenheim

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

135

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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)

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tidsperspektiver: Tilbagevirkende kraft

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nutritional status at diagnosis
Tidsramme: 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)
Within the month of diagnosis
Change in nutritional status during treatment
Tidsramme: 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
Every month during the treatment period (average treatment period 11 months)
Change in nutritional status during follow-up
Tidsramme: 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
Once in a period of three months during two years follow-up

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2013

Primær færdiggørelse (Faktiske)

1. januar 2014

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

17. september 2014

Først indsendt, der opfyldte QC-kriterier

19. september 2014

Først opslået (Skøn)

22. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EM-13

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