Health Trials

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 groups

Locations

4
Aalborg University Hospital9000, Aalborg Denmark
Aarhus University Hospital8200, Aarhus Denmark
Rigshospitalet2100, Copenhagen Denmark
Odense University Hospital5000, Odense Denmark

Sponsors 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