Using lithium to prevent cognitive decline after brain radiotherapy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of oral lithium treatment in preventing cognitive decline in pediatric brain tumor survivors who have undergone brain radiotherapy. It is a randomized, placebo-controlled, double-blinded study that will assess cognitive processing speed and other neuropsychological outcomes over a period of 6 months to 2 years. Participants will include children aged 5 and older who have received cranial radiation within the last 7 years. The study aims to explore the safety and tolerability of lithium while evaluating its potential neuroprotective effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hope
  Stockholm, Sweden Recruiting
• Karolinska Universitetssjukhuset
  Solna, Stockholm County, Sweden Not yet recruiting

Study contacts

• Study coordinator: Klas Blomgren, MD, Professor
• Email: klas.blomgren@regionstockholm.se
• Phone: 0046703233353

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.