Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-27
SponsorOdense University Hospital
About this trial
Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking.
The researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit/hyperactivity disorder (ADHD).
If methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.
Eligibility criteria
Qualifiers
Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).
Treated for a PBT during the previous 10 years, starting from date of diagnosis.
Aged ≥6 years 0 months at the start of the trial.
Off therapy/active treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial.
Disqualifiers
History of recent poorly controlled seizures.
Motor tics or Tourette syndrome (including family history of tic disorder).
Known diagnosis of Attention Deficit/Hyperactivity Disorder or Autism Spectrum Disorder.
Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of <50.
Trial design
Treatments tested in this trial
- Methylphenidate (MPH)
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Odense University Hospital
Lead sponsor
Aarhus University Hospital Skejby
Collaborator
Aalborg University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
University of Southern Denmark
Collaborator
Source ClinicalTrials.gov