Using lithium to prevent cognitive decline after brain radiotherapy in children
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
This study is testing if taking lithium can help prevent memory and thinking problems in children who have survived brain tumors and received radiation therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Drugs / interventions | radiation |
| Locations | 2 sites (Solna, Stockholm County and 1 other locations) |
| Trial ID | NCT06051240 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 18 who have received cranial or craniospinal radiation for brain tumors within the last 7 years.
Not a fit: Patients with renal failure, cardiac issues, or those who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive outcomes and quality of life for pediatric brain tumor survivors.
How similar studies have performed: While there is limited research on lithium for this specific purpose, similar neuroprotective approaches have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Solna, Stockholm County and 1 other locations
- Karolinska Universitetssjukhuset — Solna, Stockholm County, Sweden (Not_yet_recruiting)
- Hope — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Klas Blomgren, MD, Professor
- Email: klas.blomgren@regionstockholm.se
- Phone: 0046703233353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.