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

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

Plain Language Summary

Simplified for easier understanding

This study tests whether the mood-stabilizing drug lithium can help protect the thinking and memory abilities of children who received brain radiation as part of cancer treatment. Radiation to the brain can cause long-term cognitive problems, and researchers hope lithium may help prevent or reduce this. **You may be eligible if...** - You (or your child) received radiation to the brain or spine for a brain tumor within the past 7 years - You were under 18 years old at the time of radiation and are now older than 5 - You use effective contraception if you could become pregnant **You may NOT be eligible if...** - You have an allergy to lithium - You have kidney disease, heart disease, or thyroid problems - You have severe electrolyte or fluid imbalances - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLithium

Lithium sulphate, 42 mg (6 mmol lithium)

DRUGPlacebo

White round tablet, 10 mm. Identical to experimental drug (lithium)


Locations(2)

Karolinska Universitetssjukhuset

Solna, Stockholm County, Sweden

HOPE

Stockholm, Sweden

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NCT06051240


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