Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue (NCT06905587) | Clinical Trial Compass
RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Denmark50 participantsStarted 2025-09-02
Plain-language 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.
Who can participate
Age range
6 Years – 27 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. No known signs of clinical or radiological tumor progression at last follow-up.
. Danish is the sole or primary language (enabling provision of validated assessment tools).
. Patient and family have provided consent for inclusion in the trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PedsQL Multidimensional Fatigue Scale (MFS)
Timeframe: At baseline, at Week 6, Week 16, and Week 20 (follow-up).
. Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean.
Exclusion criteria
. Any known contraindications to methylphenidate as outlined below:
. 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.
. 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.
. Concerns about family ability to safely store or administer MPH, or to report side effects appropriately/concerns about familial substance abuse.
. Concurrent use of opiods (ATC N02A) or benzodiazepines (ATC N05BA and N05CF).