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Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

Effect of Methylphenidate on Cancer-related Fatigue in Patients Treated for a Brain Tumor During Childhood or Adolescence: Protocol for a Randomized, Double-blind, Placebo-controlled Crossover Trial - the EMBRAIN Trial

NCT06905587•Odense University Hospital

View on ClinicalTrials.gov

Summary

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

Age

6 - 27 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).
•2. Treated for a PBT during the previous 10 years, starting from date of diagnosis.
•3. Aged ≥6 years 0 months at the start of the trial.
•4. Off therapy/active treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial.
•5. No known signs of clinical or radiological tumor progression at last follow-up.
•6. Danish is the sole or primary language (enabling provision of validated assessment tools).
•7. Patient and family have provided consent for inclusion in the trial.
•8. Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean.
•9. History of clinically relevant fatigue after treatment of PBT compared to estimated premorbid ability, as assessed from consultations in the childhood cancer outpatient clinics.

Exclusion Criteria

•1. Any known contraindications to methylphenidate as outlined below:
•A) Hypersensitivity to the active substance or any excipients listed in the summary of product characteristics. B) Glaucoma. C) Pheochromocytoma. D) Hyperthyroidism. E) Mania. F) Psychosis. G) Anorexia nervosa. H) Current or previous severe depression. I) Suicidal behavior. J) Poorly controlled type 1 bipolar affective disorder. K) Antisocial or borderline personality disorder. L) Pre-existing cardiovascular disorders, including severe hypertension, heart failure, arterial occlusive disease, angina pectoris, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening cardiac arrhythmias and channelopathies. M) Pre-existing cerebrovascular disease, cerebral aneurysm, vascular abnormalities including vasculitis or stroke. N) Treatment with irreversible MAO inhibitors within the last 14 days and reversible MAO inhibitors within the last 24 hours.
•2. History of recent poorly controlled seizures.
•3. Motor tics or Tourette syndrome (including family history of tic disorder).
•4. Known diagnosis of Attention Deficit/Hyperactivity Disorder or Autism Spectrum Disorder.
•5. Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of \<50.
•6. Pregnancy. Participants known to be pregnant or breastfeeding at screening/registration will not be enrolled in the trial. All sexually active women of childbearing potential (WOCBP) must have a negative pregnancy test prior to the start of treatment. Acceptableeffective contraceptive must be used for the duration of the trial. No further testing is needed during trial, unless the participant suspects to have become pregnant.
•7. Concerns about family ability to safely store or administer MPH, or to report side effects appropriately/concerns about familial substance abuse.
•8. Concurrent use of opiods (ATC N02A) or benzodiazepines (ATC N05BA and N05CF).
•9. Simultaneously enrolled in another clinical trial investigating cancer-related fatigue with a pharmaceutical intervention.

Locations (4)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

Key Dates

Start Date

September 2, 2025

Primary Completion Date

December 1, 2029

Completion Date

December 1, 2029

Last Updated

December 11, 2025

Enrollment

ESTIMATED participants

Conditions

Brain Tumor, PediatricCancer-related FatigueMethylphenidate

Interventions

Methylphenidate (MPH)

DRUG

Placebo

DRUG

Contacts

Sebastian W Most-Mottelson, MD, PhD Student

CONTACT

+45 21567257 sebastian.wenzel.most-mottelson@rsyd.dk

Mathias Rathe, Consultant, MD, PhD

CONTACT

+45 20469682 mathias.rathe@rsyd.dk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

Inclusion Criteria

Exclusion Criteria

Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT)

Utility of PET-MRI in Surveillance of Paediatric Brain Tumours

Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With ADHD

Social Emotional Development in Young Children With Cancer

Wearable Technology-Supported Exercise Program for Fatigue and Quality of Life in Pediatric Cancer Patients (WE-EX PedsCa)

PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder