MalnutritionNCT02246452
Assessment of the Nutritional Status of Children and Adolescents With Malignancies
An observational study of Malnutrition, run by University of Hohenheim.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Malnutrition
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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)
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Malnutrition
- Keywords
- Children and adolescents, Cancer, Malnutrition, BMI percentile, BMI-SDS
- Medical subject headings
- Malnutrition, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status at 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)
Measured: Within the month of diagnosis
Change in nutritional status during treatment
To assess the nutritional status height and weight were recorded from patient charts to calculate the BMI percentile and the BMI-SDS
Measured: Every month during the treatment period (average treatment period 11 months)
Change in nutritional status during follow-up
To assess the nutritional status height and weight were recorded from patient chart to calculate the BMI percentile and the BMI-SDS
Measured: Once in a period of three months during two years follow-up
Secondary outcomes (13)
Clinical picture
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
Measured: Within the month of diagnosis
Age (years)
Age in years, recorded from patient chart
Measured: Within the month of diagnosis
Treatment period (months)
Time from start until the end of treatment, recorded from patient chart
Measured: Patients were followed for the duration of their treatment period. Average treatment period 11 months
Incidence of nutritional interventions
Application of parenteral nutrition or gastric tube (yes/no), recorded from patient chart
Measured: Patients were followed for the incidence of a nutritional intervention within the treatment period (average treatment period 11 months)
Infection
Occurence of an infection (yes/no), recorded from patient chart
Measured: Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)
Fever
Occurence of fever (yes/no), recorded from patient chart
Measured: Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)
Administration of antibiotics
Administration of antibiotics (yes/no), recorded from patient chart
Measured: Patients were followed for the occurence of an administration of antibiotics within the treatment period (average treatment period 11 months)
Diarrhea
Occurence of diarrhea (yes/no), recorded from patient chart
Measured: Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)
Mucositis
Occurence of mucositis (yes/no),recorded from patient chart
Measured: Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)
Nausea
Occurence of nausea (yes/no), recorded from patient chart
Measured: Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)
Constipation
Occurence of constipation (yes/no), recorded from patient chart
Measured: Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)
Relapse/Progress
Occurence of a relapse/progress (yes/no), recorded from patient chart
Measured: 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
Kind of treatment (chemotherapy, operation, Radiation), recorded from Patient chart
Measured: Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- Olgahospital Stuttgart
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246452
- Sponsor's protocol ID
- EM-13
- Status last verified
- Sep 2014
- First submitted
- 17 Sep 2014
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02246452
- Acronym / sponsor ID
- EM-13
- Conditions
- Malnutrition
- Keywords
- Children and adolescents, Cancer, Malnutrition, BMI percentile, BMI-SDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- Olgahospital Stuttgart
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
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
13 secondary outcomes
Clinical picture
Time frame: Within the month of diagnosis
Age (years)
Time frame: Within the month of diagnosis
Treatment period (months)
Time frame: Patients were followed for the duration of their treatment period. Average treatment period 11 months
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)
Infection
Time frame: Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)
Fever
Time frame: Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)
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)
Diarrhea
Time frame: Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)
Mucositis
Time frame: Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)
Nausea
Time frame: Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)
Constipation
Time frame: Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)
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)
Kind of treatment
Time frame: Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by University of Hohenheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status at diagnosis (time frame: Within the month of diagnosis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.