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NCT Number: NCT02246452

Assessment of the Nutritional Status of Children and Adolescents With Malignancies

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.

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Key information

Conditions

Malnutrition Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Nutritional status at diagnosis

    Time frame: 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)

  2. Change in nutritional status during treatment

    Time frame: 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

  3. Change in nutritional status during follow-up

    Time frame: 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

Secondary outcomes

  1. Clinical picture

    Time frame: 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

  2. Age (years)

    Time frame: Within the month of diagnosis

    Age in years, recorded from patient chart

  3. Treatment period (months)

    Time frame: 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

  4. Incidence of nutritional interventions

    Time frame: 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

  5. Infection

    Time frame: 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

  6. Fever

    Time frame: 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

  7. Administration of antibiotics

    Time frame: 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

  8. Diarrhea

    Time frame: 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

  9. Mucositis

    Time frame: 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

  10. Nausea

    Time frame: 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

  11. Constipation

    Time frame: 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

  12. Relapse/Progress

    Time frame: 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

  13. Kind of treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Collaborators

  • Olgahospital Stuttgart

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2014
Registry last updated
Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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