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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Methylphenidate (MPH)
Drug10 mg methylphenidate tablets with a scoreline. Tablets will be administered orally. For children aged 6-12, a daily dose of 5 mg x 2 will be administered during the first week with an increase in dose to 10 mg x 2 in the second week. For adolescents and adults above 12 years of age, the same starting dose will be used as for children, with weekly incremental increases up to a maximum of 15 mg x 2 daily in the third week. In case of potential toxicity events during study, dosage of methylphenidate can be modified according to protocol.
Placebo
Drug10 mg methylphenidate-matched placebo tablets with a scoreline. Tablets will be administered orally. Dosage will follow the exact same principles as for the study drug (methylphenidate).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Methylphenidate, Then PlaceboExperimental treatment 2 interventions
Group B: Placebo, Then MethylphenidateExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
PedsQL Multidimensional Fatigue Scale (MFS)
Changes in patient self-reported fatigue (participants above 18 years of age) or parent proxy-reported fatigue (participants between 6-17 years of age) from baseline to week 6 of MPH or placebo treatment as measured by the PedsQL Multidimensional Fatigue Scale (MFS).
Time frame
At baseline, at Week 6, Week 16, and Week 20 (follow-up).Secondary outcomes
1
PedsQL Multidimensional Fatigue Scale (MFS)
Changes from baseline in self-reported fatigue (participants aged 6-17 years of age) measured by the PedsQL MFS.
Time frame
At baseline, at Week 6, Week 16, and Week 20 (follow-up).2
Behaviour Rating Inventory of Executive Function (BRIEF)
Changes from baseline in self and parent-reported executive function measured by the BRIEF-2 or BRIEF-V questionnaire.
Time frame
At baseline, at Week 6, and Week 16.3
Connor's Continuous Performance Test (CPT) Online Suite
Changes from baseline in digital measures of sustained attention and executive function. CPT-3 and K-CPT-2 will be used.
Time frame
At baseline, at Week 6, and Week 16.4
Wechsler Coding
Changes from baseline in processing speed. Coding module from Wechsler Intelligence Scale for Children Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale Fifth Edition (WAIS-V) depending on age of participant.
Time frame
At baseline, at Week 6, and Week 16.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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