NCT06380387Recruiting
Whole Body Metabolism in Children Before and After Treatment of CNS Tumor
Source: ClinicalTrials.gov · Last updated 23 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome. By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls. The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- 23 Mar 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Childhood cancers
- NCT number
- NCT06380387
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 23 Mar 2023 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intake of medications that may interfere with the results, evaluated by investigator.
Other illness
- Competing conditions at risk of compromising the results of the study.
Other
- Inability to understand the purpose of the trial or cooperate in the conduction of the experiments. For the children this will concern of course the parents or the guardians of the child.
- Participation in other trials that may interfere with the results.
- Pregnancy or breastfeeding.
Who the study is looking for
- Patient group A: Children with newly diagnosed CNS tumor, included just before the start of treatment or right after possible surgery.
- Patient group B: Children who have completed treatment for a CNS tumor within the last month.
- Healthy controls: Children admitted to the EMU because of either
- Suspected convulsions
- Nocturnal EEG changes
- 6-18 years
- Signed informed consent to participation in the trial.
Age in the registry: 6 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.