Actively Recruiting
Effect of Methylphenidate on Cancer-related Fatigue in Pediatric Brain Tumor Survivors: A Randomized, Double-blind, Placebo-controlled Crossover Trial
Led by Odense University Hospital · Updated on 2026-04-23
50
Participants Needed
4
Research Sites
N/A
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
Researchers are studying cancer-related fatigue, a common and challenging late effect in children and young adults who have survived brain tumors. The trial evaluates methylphenidate, a central nervous system stimulant often used for ADHD, to see if it can improve fatigue and cognitive function in pediatric brain tumor survivors. This research is important because there are currently no strong evidence-based treatments for this fatigue. Participants will receive both methylphenidate tablets and matching placebo tablets in a randomized, double-blind, crossover design. They will take methylphenidate for 6 weeks, then switch to placebo for 6 weeks, or vice versa, with a four-week washout period in between. Dosages start low and increase weekly, adjusted by age and tolerance, with monitoring for side effects. During the study, participants will undergo repeated assessments including fatigue scales, cognitive tests, and side effect ratings at multiple time points. Physical activity will be tracked with accelerometers for one week during each treatment period. The main outcome is measured by the PedsQL Multidimensional Fatigue Scale at baseline, during, and after treatments. The total participation spans several months with follow-up evaluations to monitor safety and treatment effects.
CONDITIONS
Brief 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 to 18 years).
- Treated for a pediatric brain tumor within the previous 10 years from diagnosis.
- Aged 6 years or older at the start of the trial.
- Off active therapy for the brain tumor for at least 12 months before starting the trial.
- No signs of tumor progression at last follow-up.
- Danish is the primary language.
- Patient and family have given consent to participate.
- Clinically significant fatigue based on PedsQL MFS questionnaire at baseline.
- History of clinically relevant fatigue after brain tumor treatment compared to premorbid ability.
You will not qualify if you...
- Known contraindications to methylphenidate such as hypersensitivity, glaucoma, pheochromocytoma, hyperthyroidism, mania, psychosis, anorexia nervosa, severe depression, suicidal behavior, bipolar disorder, personality disorders, cardiovascular or cerebrovascular diseases.
- Treatment with MAO inhibitors recently.
- History of poorly controlled seizures.
- Motor tics or Tourette syndrome.
- Diagnosis of ADHD or Autism Spectrum Disorder.
- Full Scale IQ below 50.
- Pregnancy or breastfeeding; women of childbearing potential must use effective contraception.
- Concerns about family ability to safely manage methylphenidate.
- Current use of opioids or benzodiazepines.
- Enrolled in another clinical trial for cancer-related fatigue with drugs.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks per treatment period with a 4-week washout period between treatments
Participants receive two treatment periods in a randomized crossover design, receiving methylphenidate tablets during one period and placebo tablets during the other, with a washout period in between. Dosage starts low and may be increased weekly based on age and tolerance.
Visits at baseline, Week 2, Week 3, Week 4, Week 6, Week 10, Week 12, Week 13, Week 14, and Week 16
Duration - 4 weeks
Participants are monitored after treatment completion to assess ongoing effects and safety.
1 visit at Week 20 (follow-up)
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
M
Mathias Rathe, Consultant, MD, PhD
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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