Short summary

Cancer-related fatigue is one of the most common and debilitating symptoms in survivors of pediatric brain tumors. Methylphenidate is a central nervous stimulant most commonly used in the treatment of ADHD. In a national, multi-center study, designed as a randomized, double-blind, placebo-controlled, crossover trial, we aim to study the effects of methylphenidate treatment on cancer-related fatigue and other neurocognitive variables in survivors of pediatric brain tumors.

Rationale

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. We will investigate the ability of methylphenidate to improve fatigue, quality of life and cognition in patients suffering from cancer-related fatigue. 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.

Description of the cohort

Participants are patients diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years). Important inclusion criteria for participants are (among several others): 1. Clinically significant fatigue based on the primary endpoint "PedsQL Multidimensional Fatigue Scale" 2. Minimum 6 years of age at the start of trial 3. No active therapy for the past 12 months at the start of trial 4. Treated for a brain tumor during the previous 10 years, starting from the date of diagnosis. Participants will be recruited through the relevant study treatment center outpatient clinics.

Data and biological material

Blood samples related to common causes of fatigue. Electronic questionnaires on fatigue, quality of life, side effects and executive functioning. Neurocognitive tests on processing speed and working memory. Accelerometry. Adverse events.

Collaborating researchers and departments

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

• Louise Tram Henriksen, MD, PhD

Department of Paediatrics and Adolescent Medicine, Rigshospitalet

• Christine Dahl, Consultant, MD, PhD

Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital

Department of Sports Science, University of Southern Denmark

• Jan Christian Brønd, Associate Professor, PhD