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Assessment of the Nutritional Status of Children and Adolescents With Malignancies

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ClinicalTrials.gov Identifier: NCT02246452
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Collaborator:
Olgahospital Stuttgart
Information provided by (Responsible Party):
University of Hohenheim

Brief Summary:
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.

Condition or disease
Malnutrition

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 135 participants
Time Perspective: Retrospective
Official 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
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

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

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Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT02246452     History of Changes
Other Study ID Numbers: EM-13
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014
Keywords provided by University of Hohenheim:
Children and adolescents
Cancer
Malnutrition
BMI percentile
BMI-SDS
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders