Assessment of the Nutritional Status of Children and Adolescents With Malignancies
19. září 2014 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
135
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
Ne starší než 18 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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)
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Časové perspektivy: Retrospektivní
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Nutritional status at diagnosis
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Clinical picture
Časové okno: 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)
Časové okno: Within the month of diagnosis
|
Age in years, recorded from patient chart
|
Within the month of diagnosis
|
|
Treatment period (months)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. června 2013
Primární dokončení (Aktuální)
1. ledna 2014
Dokončení studie (Aktuální)
1. ledna 2014
Termíny zápisu do studia
První předloženo
17. září 2014
První předloženo, které splnilo kritéria kontroly kvality
19. září 2014
První zveřejněno (Odhad)
22. září 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
22. září 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. září 2014
Naposledy ověřeno
1. září 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EM-13
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