Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

2023-504071-24-00

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.

2024-02-16

2030-08-31

2033-08-31

Recruiting

Early phase I

84

Inclusion Criteria: * 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. * Negative pregnancy test\* at screening, at start of study treatment, and monthly thereafter. * Written informed consent from patient and/or caregiver. Exclusion Criteria: * 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. * Pregnancy or breast feeding. * Severe fluid or electrolyte imbalance. * Karnofsky-Lansky score \< 60. * Other condition deemed incompatible with inclusion in this study (estimated 2 year survival prognosis less than 25 %, expected poor protocol compliance, inability to swallow tablets, language difficulties). * Inclusion in other study protocol precluding inclusion in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization is based on whether or not the study participant had received radiotherapy to the whole brain (CSI) or only part of it (focal irradiation). Within each of these two arms there is a predetermined block randomization with a 2:1 lithium:placebo ratio.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Identical-looking placebo is used. S-lithium levels are masked by using a separate lab service and sham values for placebo group.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}

2024-04-12