RecruitingPhase 3NCT06905587

Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

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

Sponsor

Odense University Hospital

Enrollment

50 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 6 YearsMax Age: 27 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether methylphenidate (a stimulant medication commonly used for ADHD) can reduce cancer-related fatigue in children and teenagers who survived a brain tumor and continue to experience significant tiredness long after finishing treatment. **You may be eligible if...** - You (or your child) were diagnosed with and treated for a brain tumor during childhood or adolescence - Treatment was completed within the past 10 years - You are at least 6 years old at the start of the trial - You have been off all active cancer treatment for at least 12 months - There are no signs of the tumor returning at your last checkup - Danish is your primary language - You have significant fatigue based on a standardized questionnaire **You may NOT be eligible if...** - You are currently receiving treatment for the brain tumor - There are signs of tumor progression - You have a condition that makes methylphenidate unsafe (e.g., certain heart conditions or severe anxiety) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethylphenidate (MPH)

10 mg methylphenidate tablets with a scoreline. Tablets will be administered orally. For children aged 6-12, a daily dose of 5 mg x 2 will be administered during the first week with an increase in dose to 10 mg x 2 in the second week. For adolescents and adults above 12 years of age, the same starting dose will be used as for children, with weekly incremental increases up to a maximum of 15 mg x 2 daily in the third week. In case of potential toxicity events during study, dosage of methylphenidate can be modified according to protocol.

DRUGPlacebo

10 mg methylphenidate-matched placebo tablets with a scoreline. Tablets will be administered orally. Dosage will follow the exact same principles as for the study drug (methylphenidate).