Assessment of the Nutritional Status of Children and Adolescents With Malignancies
19 september 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
135
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
Inte äldre än 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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)
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tidsperspektiv: Retrospektiv
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Nutritional status at diagnosis
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical picture
Tidsram: 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)
Tidsram: Within the month of diagnosis
|
Age in years, recorded from patient chart
|
Within the month of diagnosis
|
|
Treatment period (months)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2013
Primärt slutförande (Faktisk)
1 januari 2014
Avslutad studie (Faktisk)
1 januari 2014
Studieregistreringsdatum
Först inskickad
17 september 2014
Först inskickad som uppfyllde QC-kriterierna
19 september 2014
Första postat (Uppskatta)
22 september 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 september 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 september 2014
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EM-13
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .