Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

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.

Conditions

• Brain Tumor, Pediatric
• Cancer-related Fatigue
• Methylphenidate

Interventions

DRUG

Methylphenidate (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.

DRUG

Placebo

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).

Sponsors & Collaborators

• Aarhus University Hospital Skejby

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Mathias Rathe, Consultant, MD, PhD · Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

27 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-02

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Denmark

Study Locations