RecruitingPhase 2NCT06051240

Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Sponsor

Region Stockholm

Enrollment

84 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

Radiotherapy Side Effect Cognitive Impairment Brain Tumor Radiotherapy; Complications Cognitive Decline Memory Impairment Late Effect of Radiation

Summary

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.

Eligibility

Min Age: 5 Years

Inclusion Criteria6

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 Criteria9

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.