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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507926-18-00
Enrollment
50
Registered
2025-01-18
Start date
2025-09-02
Completion date
Unknown
Last updated
2025-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-related fatigue after treatment of pediatric brain tumor

Brief summary

Changes in patient self-reported or parent proxy-reported fatigue from baseline to week 6 of MPH or placebo treatment as measured by the PedsQL Multidimensional Fatigue Scale (MFS).

Detailed description

Changes from baseline in self and parent-reported executive function measured by the BRIEF-2., Changes from baseline in digital measures of sustained attention and executive function., Changes from baseline in standardized neurocognitive measures of processing speed and working memory., Changes from baseline in self and parent-reported measures of Health Related Quality of Life measured by the PedsQL 4.0 Generic Core Scales Module., Time spent within different activity domains and sleep-wake patterns measured by actigraphy., Changes from baseline in self and parent-reported side-effects measured by Barkley’s Side-Effects Rating Scale.

Interventions

DRUGMETHYLPHENIDATE
DRUGPLACEBO

Sponsors

Odense University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Changes in patient self-reported or parent proxy-reported fatigue from baseline to week 6 of MPH or placebo treatment as measured by the PedsQL Multidimensional Fatigue Scale (MFS).

Secondary

MeasureTime frame
Changes from baseline in self and parent-reported executive function measured by the BRIEF-2., Changes from baseline in digital measures of sustained attention and executive function., Changes from baseline in standardized neurocognitive measures of processing speed and working memory., Changes from baseline in self and parent-reported measures of Health Related Quality of Life measured by the PedsQL 4.0 Generic Core Scales Module., Time spent within different activity domains and sleep-wake patterns measured by actigraphy., Changes from baseline in self and parent-reported side-effects measured by Barkley’s Side-Effects Rating Scale.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026