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
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.
• 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.
• Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean.
• History of clinically relevant fatigue after treatment of PBT compared to estimated premorbid ability, as assessed from consultations in the childhood cancer outpatient clinics.