METHYLPHENIDATE for Cancer-related fatigue | Brain tumor

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Any known contraindications to methylphenidate medication as outlined below: A)\tHypersensitivity to the active substance or any excipients listed in the summary of product characteristics. B)\tGlaucoma. C)\tPheochromocytoma. D)\tHyperthyroidism. E)\tMania. F)\tPsychosis. G)\tAnorexia nervosa. H)\tCurrent or previous severe depression. I)\tSuicidal behavior. J)\tPoorly controlled type 1 bipolar affective disorder. K)\tAntisocial or borderline personality disorder. L)\tPre-existing cardiovascular disorders, including severe hypertension, heart failure, arterial occlusive disease, angina pectoris, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening cardiac arrhythmias and channelopathies. M)\tPre-existing cerebrovascular disease, cerebral aneurysm, vascular abnormalities including vasculitis or stroke. N)\tTreatment with irreversible MAO inhibitors within the last 14 days and reversible MAO inhibitors within the last 24 hours.\n- History of recent poorly controlled seizures.\n- Motor tics or Tourette syndrome (including family history of tic disorder).\n- Known diagnosis of Attention Deficit/Hyperactivity Disorder or Autism Spectrum Disorder.\n- Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of <50.\n- Pregnancy. Participants known to be pregnant or breastfeeding at screening/registration will not be enrolled in the trial. All sexually active women of childbearing potential (WOCBP) must have a negative pregnancy test prior to the start of treatment. Acceptable effective contraceptive must be used for the duration of the trial, per guidelines by the Clinical Trials Coordination Group (CTCG). No further testing is needed during trial, unless the participant suspects to have become pregnant.\n- Concerns about family ability to safely store or administer MPH, or to report side effects appropriately/concerns about familial substance abuse.\n- Concurrent use of opiods (ATC N02A) or benzodiazepines (ATC N05BA and N05CF).\n- Simultaneously enrolled in another clinical trial investigating cancer-related fatigue with a pharmaceutical intervention."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Fatigue measured by the PedsQL Multidimensional Fatigue Scale (MFS); change from baseline to week 6; assessed via patient self-report or parent proxy-report."}

Secondary endpoints

• {"endpoint_text":"- Changes from baseline in self and parent-reported executive function measured by the BRIEF-2.","definition_or_measurement_approach":"Executive function assessed by BRIEF-2; change from baseline."}
• {"endpoint_text":"- Changes from baseline in digital measures of sustained attention and executive function.","definition_or_measurement_approach":"Digital measures of sustained attention and executive function; change from baseline (specific digital tools not detailed in JSON)."}
• {"endpoint_text":"- Changes from baseline in standardized neurocognitive measures of processing speed and working memory.","definition_or_measurement_approach":"Standardized neurocognitive tests measuring processing speed and working memory; change from baseline."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Health Related Quality of Life measured by PedsQL 4.0 Generic Core Scales; change from baseline via self and parent reports."}
• {"endpoint_text":"- Time spent within different activity domains and sleep-wake patterns measured by actigraphy.","definition_or_measurement_approach":"Actigraphy to quantify time in activity domains and sleep-wake patterns."}
• {"endpoint_text":"- Changes from baseline in self and parent-reported side-effects measured by Barkley’s Side-Effects Rating Scale.","definition_or_measurement_approach":"Side-effects assessed via Barkley’s Side-Effects Rating Scale; change from baseline."}

Denmark

Earliest CTIS Part Ii Submission Date

02-12-2024

Latest Decision Or Authorization Date

18-01-2025

Processing Time Days

47

Number Of Sites

4

Number Of Participants

50

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Glostrup Apotek","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: [1,10,7,8]","organisation_type":"Hospital/Clinic/Other health care facility"}