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โ† Trials
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Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

RecruitingPhase 2Ages 5 Years - anyAllRegion Stockholm
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Lithium
  • Placebo
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Where

2 sites
Karolinska Universitetssjukhuset
Solna, Sweden
HOPE
Stockholm, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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