Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

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.