Actively Recruiting
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Led by Odense University Hospital · Updated on 2026-04-23
50
Participants Needed
4
Research Sites
221 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
A
Aarhus University Hospital Skejby
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).
- Treated for a pediatric brain tumor within the past 10 years from diagnosis.
- Aged 6 years 0 months or older at study start.
- Completed brain tumor therapy at least 12 months before starting the trial.
- No clinical or radiological signs of tumor progression at last follow-up.
- Danish as the primary or sole language for valid assessment.
- Patient and family have provided consent to participate.
- Clinically significant fatigue by PedsQL MFS score at baseline (≥1 standard deviation below normative mean).
- History of significant fatigue after brain tumor treatment compared to estimated premorbid ability.
You will not qualify if you...
- Known contraindications to methylphenidate including hypersensitivity, glaucoma, pheochromocytoma, hyperthyroidism, mania, psychosis, anorexia nervosa, severe depression, suicidal behavior, poorly controlled bipolar disorder, antisocial or borderline personality disorder, pre-existing severe cardiovascular or cerebrovascular diseases.
- Treatment with irreversible MAO inhibitors within 14 days or reversible MAO inhibitors within 24 hours.
- History of recent poorly controlled seizures.
- Motor tics or Tourette syndrome or family history of tic disorder.
- Known diagnosis of ADHD or autism spectrum disorder.
- Full Scale Intelligence Quotient (FSIQ) below 50.
- Pregnancy or breastfeeding; women of childbearing potential must have a negative pregnancy test and use effective contraception during the trial.
- Concerns about family’s ability to safely store or administer methylphenidate or report side effects.
- Current use of opioids or benzodiazepines.
- Participation in another cancer-related fatigue drug trial simultaneously.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
3
Rigshospitalet
Copenhagen, Denmark, 2100
Not Yet Recruiting
4
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
S
Sebastian W Most-Mottelson, MD, PhD Student
CONTACT
M
Mathias Rathe, Consultant, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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