Randomized, placebo-controlled, double-blinded, parallel group clinical trial to investigate if 6 months of oral lithium tablets (S-lithium 0,5-1,0 mmol/l) will prevent cognitive decline after brain radiotherapy in pediatric brain tumor survivors.
Primary outcome measure is Processing Speed Index (PSI) 2 years after start of study treatment.
Age >5 years.
Age <18 years at time of radiotherapy.
Has received cranial/craniospinal radiation treatment of brain tumor within the last 7 years.
Adequate contraceptive method to prevent pregnancy* during the entire lithium treatment period and six months thereafter.
Allergy/hypersensitivity to lithium or any of the excipients
Renal failure (Cystatin C derived Glomerular Filtration Rate < 60).
Cardiac failure or heart disease, including Brugada syndrome (or family history thereof).
Uncontrolled hypothyroidism.
Parallel
Lithium
DrugLithium sulphate, 42 mg (6 mmol lithium)
Placebo
DrugWhite round tablet, 10 mm. Identical to experimental drug (lithium)
Processing Speed Index (PSI)
Cognitive processing speed. Normed score min 45, max 155. Higher = better.
Fractional anisotropy (FA) index
White matter integrity on MRI brain.
Other Wechsler Intelligence scale scores (except PSI):
* Verbal Comprehension Index (VCI) * Visual Spatial Index (VSI) * Fluid Reasoning Index (FRI) * Working Memory Index (WMI) Normed score min 45, max 155. Higher = better.
Grooved pegboard
Motor speed / manual dexterity. Unit: time in seconds to complete all pegs. Lower=better.
Beery/Buktenica visual motor integration (VMI)
Visual motor integration. Normed score min 1, max 19. Higher = better.
Feasibility of recruitment and retention, numerical data
* Number of potentially eligible patients identified * Number of patients screened * Number of patients randomized * Number of patients completing the study per protocol * Number of patients terminating study during IMP treatment period (6 months). * Number of patients terminating study during follow-up period (up 5 years post IMP treatment)
Feasibility of recruitment and retention, qualitative data
* Description of reason why eligle patient declined screening * Description of reason why screened patient was not randomized/included * Description of reason(s) for early study termination.
Feasibility of treatment - IMP treatment duration
Duration of IMP treatment, measured in total number of days where IMP was taken
Feasibility of treatment - number of IMP reductions and stops
* Numbers of IMP dose reductions * Number of IMP temporary stops
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Region Stockholm
Lead sponsor
Rigshospitalet, Denmark
Collaborator
