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.
Region Stockholm
Lead sponsor
Rigshospitalet, Denmark
Collaborator