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Recruiting Phase 3 NCT06905587

Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

Trial Parameters

Condition Brain Tumor, Pediatric
Sponsor Odense University Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 50
Sex ALL
Min Age 6 Years
Max Age 27 Years
Start Date 2025-09-02
Completion 2029-12
Interventions
Methylphenidate (MPH)Placebo

Brief 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 Criteria

Inclusion Criteria: 1. Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years). 2. Treated for a PBT during the previous 10 years, starting from date of diagnosis. 3. Aged ≥6 years 0 months at the start of the trial. 4. Off therapy/active treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial. 5. No known signs of clinical or radiological tumor progression at last follow-up. 6. Danish is the sole or primary language (enabling provision of validated assessment tools). 7. Patient and family have provided consent for inclusion in the trial. 8. Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean. 9. History of clinically relevant fatigue after treatment of PBT compared to estimated premorbid ability, as assessed from consultations in the childhood cancer outpatient clinics. Exclusion Criteria: 1. Any known contraindications to methylpheni

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