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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
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.
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).
Aalborg University Hospital
Aalborg, Denmark
NOT_YET_RECRUITINGAarhus University Hospital
Aarhus, Denmark
NOT_YET_RECRUITINGRigshospitalet
Copenhagen, Denmark
NOT_YET_RECRUITINGOdense University Hospital
Odense, Denmark
RECRUITINGPedsQL Multidimensional Fatigue Scale (MFS)
Changes in patient self-reported fatigue (participants above 18 years of age) or parent proxy-reported fatigue (participants between 6-17 years of age) from baseline to week 6 of MPH or placebo treatment as measured by the PedsQL Multidimensional Fatigue Scale (MFS).
Time frame: At baseline, at Week 6, Week 16, and Week 20 (follow-up).
PedsQL Multidimensional Fatigue Scale (MFS)
Changes from baseline in self-reported fatigue (participants aged 6-17 years of age) measured by the PedsQL MFS.
Time frame: At baseline, at Week 6, Week 16, and Week 20 (follow-up).
Behaviour Rating Inventory of Executive Function (BRIEF)
Changes from baseline in self and parent-reported executive function measured by the BRIEF-2 or BRIEF-V questionnaire.
Time frame: At baseline, at Week 6, and Week 16.
Connor's Continuous Performance Test (CPT) Online Suite
Changes from baseline in digital measures of sustained attention and executive function. CPT-3 and K-CPT-2 will be used.
Time frame: At baseline, at Week 6, and Week 16.
Wechsler Coding
Changes from baseline in processing speed. Coding module from Wechsler Intelligence Scale for Children Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale Fifth Edition (WAIS-V) depending on age of participant.
Time frame: At baseline, at Week 6, and Week 16.
Wechsler Digit Span
Changes from baseline in working memory. Coding module from WISC-V or WAIS-V depending on age of participant.
Time frame: At baseline, at Week 6, and Week 16.
PedsQL Generic Core Scales
Changes from baseline in self and parent-reported measures of Health Related Quality of Life.
Time frame: At baseline, at Week 6, and Week 16.
Accelerometry (Axivity AX3)
Time spent within different activity domains and sleep-wake patterns measured by accelerometry. Axivity AX3 accelerometers will be used.
Time frame: Accelerometry will be performed for a duration of 1 week during week 4-6 and week 14-16 during the study arm.
Barkley's Stimulant Side Effect Rating Scale (SSERS)
Changes from baseline in self and parent-reported side-effects. A modified version of SSERS with 21 items customized to Danish practice will be used.
Time frame: At baseline, Week 2, Week 3, Week 4, Week 6, Week 10, Week 12, Week 13, Week 14, Week 16, and Week 20 (follow-up)..
Sebastian W Most-Mottelson, MD, PhD Student
CONTACT
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