- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02246452
Assessment of the Nutritional Status of Children and Adolescents With Malignancies
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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Aikanäkymät: Takautuva
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Nutritional status at diagnosis
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Clinical picture
Aikaikkuna: 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)
Aikaikkuna: Within the month of diagnosis
|
Age in years, recorded from patient chart
|
Within the month of diagnosis
|
Treatment period (months)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- EM-13
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