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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
EU CTIS ID: 2023-507926-18-00
What this study is testing
To evaluate the efficacy of methylphenidate to alleviate cancer-related fatigue in patients treated for a pediatric brain tumor and screened as having cancer-related fatigue
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).
- Treated for a brain tumor during the previous 10 years.
- Age ≥6 and <28 years at the start of the trial.
- Off therapy/active treatment for 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).
You likely can't join if
- Any known contraindications to methylphenidate medication 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.
- History of recent poorly controlled seizures.
- Complex 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. Acceptable effective contraceptive must be used for the duration of the trial, per guidelines by the Clinical Trials Coordination Group (CTCG). No further testing is needed during trial, unless the participant suspects to have become pregnant.
See the full eligibility criteria
Who can join
- Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).
- Treated for a brain tumor during the previous 10 years.
- Age ≥6 and <28 years at the start of the trial.
- Off therapy/active treatment for 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/or legal guardians have provided consent for inclusion in the trial.
- Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean (self-report for adults above ≥ 18 years of age and proxy-report for minors below < 18 years of age).
- History of clinically relevant fatigue after treatment of pediatric brain tumor compared to estimated premorbid ability, as assessed from consultations in the childhood cancer outpatient clinics.
What rules you out
- Any known contraindications to methylphenidate medication 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.
- History of recent poorly controlled seizures.
- Complex 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. Acceptable effective contraceptive must be used for the duration of the trial, per guidelines by the Clinical Trials Coordination Group (CTCG). 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).
- Simultaneously enrolled in another clinical trial investigating cancer-related fatigue with a pharmaceutical intervention.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.