<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246452</url>
  </required_header>
  <id_info>
    <org_study_id>EM-13</org_study_id>
    <nct_id>NCT02246452</nct_id>
  </id_info>
  <brief_title>Assessment of the Nutritional Status of Children and Adolescents With Malignancies</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hohenheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Olgahospital Stuttgart</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Hohenheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study was the assessment of the nutritional status of children and&#xD;
      adolescents aged between 0-18 with malignancies based on BMI percentiles and standard&#xD;
      deviation scores, at diagnosis, during treatment and during a period of two years after the&#xD;
      end of therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children and adolescents suffering from malignancies often show malnutrition. Malnutrition,&#xD;
      defined as a deficiency or an excess of energy, is associated with an increased risk of&#xD;
      comorbidities, reduced survival rates, higher relapse rates, and worse treatment response.&#xD;
&#xD;
      The present retrospective study assessed the nutritional status of children and adolescents,&#xD;
      suffering from nine different kinds of cancer, based on BMI percentiles and standard&#xD;
      deviation scores. Anthropometric data were recorded from clinical charts and an assessment of&#xD;
      the nutritional status was made at the beginning of treatment, during the course of therapy&#xD;
      and during a follow-up period of two years. The influence of treatment-related&#xD;
      characteristics, the duration of therapy, and the occurrence of a relapse or progress during&#xD;
      therapy on the nutritional status were examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nutritional status at diagnosis</measure>
    <time_frame>Within the month of diagnosis</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in nutritional status during treatment</measure>
    <time_frame>Every month during the treatment period (average treatment period 11 months)</time_frame>
    <description>To assess the nutritional status height and weight were recorded from patient charts to calculate the BMI percentile and the BMI-SDS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in nutritional status during follow-up</measure>
    <time_frame>Once in a period of three months during two years follow-up</time_frame>
    <description>To assess the nutritional status height and weight were recorded from patient chart to calculate the BMI percentile and the BMI-SDS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical picture</measure>
    <time_frame>Within the month of diagnosis</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age (years)</measure>
    <time_frame>Within the month of diagnosis</time_frame>
    <description>Age in years, recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment period (months)</measure>
    <time_frame>Patients were followed for the duration of their treatment period. Average treatment period 11 months</time_frame>
    <description>Time from start until the end of treatment, recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of nutritional interventions</measure>
    <time_frame>Patients were followed for the incidence of a nutritional intervention within the treatment period (average treatment period 11 months)</time_frame>
    <description>Application of parenteral nutrition or gastric tube (yes/no), recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)</time_frame>
    <description>Occurence of an infection (yes/no), recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fever</measure>
    <time_frame>Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)</time_frame>
    <description>Occurence of fever (yes/no), recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Administration of antibiotics</measure>
    <time_frame>Patients were followed for the occurence of an administration of antibiotics within the treatment period (average treatment period 11 months)</time_frame>
    <description>Administration of antibiotics (yes/no), recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diarrhea</measure>
    <time_frame>Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)</time_frame>
    <description>Occurence of diarrhea (yes/no), recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucositis</measure>
    <time_frame>Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)</time_frame>
    <description>Occurence of mucositis (yes/no),recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)</time_frame>
    <description>Occurence of nausea (yes/no), recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constipation</measure>
    <time_frame>Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)</time_frame>
    <description>Occurence of constipation (yes/no), recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse/Progress</measure>
    <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)</time_frame>
    <description>Occurence of a relapse/progress (yes/no), recorded from patient chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kind of treatment</measure>
    <time_frame>Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)</time_frame>
    <description>Kind of treatment (chemotherapy, operation, Radiation), recorded from Patient chart</description>
  </secondary_outcome>
  <enrollment type="Actual">135</enrollment>
  <condition>Malnutrition</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children and adolescents, treated for one of the following diseases: lymphoma, germ cell&#xD;
        tumor, nephroblastoma, soft tissue sarcoma, neuroblastoma, Ewing sarcoma, brain tumor, or&#xD;
        acute lymphoblastic leukemia (ALL)/acute myeloid leukemia (AML)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children and adolescents treated at the Olgahospital Stuttgart for one of the nine&#xD;
             different cancer types&#xD;
&#xD;
          -  treated according to a study protocol of the Society of Pediatric Oncology and&#xD;
             Hematology (GPOH), with modifications only allowed within the therapeutic protocol&#xD;
&#xD;
          -  time period between diagnosis and start of treatment less than 28 days&#xD;
&#xD;
          -  age younger than 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe underlying disease, which exerts a strong influence on weight and/or height&#xD;
&#xD;
          -  patients whose clinical record does not state any weight and/or height&#xD;
&#xD;
          -  diseases which are not considered as malignant because of the state or biology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Children and adolescents</keyword>
  <keyword>Cancer</keyword>
  <keyword>Malnutrition</keyword>
  <keyword>BMI percentile</keyword>
  <keyword>BMI-SDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246452
org study id: EM-13
nct id: NCT02246452
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
time perspective: Retrospective
measure: Nutritional status at diagnosis
time frame: Within the month of diagnosis
description: 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)
measure: Change in nutritional status during treatment
time frame: Every month during the treatment period (average treatment period 11 months)
description: To assess the nutritional status height and weight were recorded from patient charts to calculate the BMI percentile and the BMI-SDS
measure: Change in nutritional status during follow-up
time frame: Once in a period of three months during two years follow-up
description: To assess the nutritional status height and weight were recorded from patient chart to calculate the BMI percentile and the BMI-SDS
measure: Clinical picture
time frame: Within the month of diagnosis
description: 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
measure: Age (years)
time frame: Within the month of diagnosis
description: Age in years, recorded from patient chart
measure: Treatment period (months)
time frame: Patients were followed for the duration of their treatment period. Average treatment period 11 months
description: Time from start until the end of treatment, recorded from patient chart
measure: 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)
description: Application of parenteral nutrition or gastric tube (yes/no), recorded from patient chart
measure: Infection
time frame: Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)
description: Occurence of an infection (yes/no), recorded from patient chart
measure: Fever
time frame: Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)
description: Occurence of fever (yes/no), recorded from patient chart
measure: 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)
description: Administration of antibiotics (yes/no), recorded from patient chart
measure: Diarrhea
time frame: Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)
description: Occurence of diarrhea (yes/no), recorded from patient chart
measure: Mucositis
time frame: Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)
description: Occurence of mucositis (yes/no),recorded from patient chart
measure: Nausea
time frame: Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)
description: Occurence of nausea (yes/no), recorded from patient chart
measure: Constipation
time frame: Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)
description: Occurence of constipation (yes/no), recorded from patient chart
measure: 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)
description: Occurence of a relapse/progress (yes/no), recorded from patient chart
measure: Kind of treatment
time frame: Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)
description: Kind of treatment (chemotherapy, operation, Radiation), recorded from Patient chart
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Malnutrition