Status:
RECRUITING
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
Lead Sponsor:
Region Stockholm
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Cognitive Impairment
Cognitive Decline
Eligibility:
All Genders
5+ years
Phase:
PHASE2
Brief 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 r...
Detailed Description
Late-appearing cognitive side effects after brain radiotherapy is a potential disabling condition in pediatric brain tumor survivors. It can have profound negative effects on education, career options...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2033
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06051240
Start Date
February 16 2024
End Date
August 31 2033
Last Update
April 12 2024
Active Locations (2)
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1
Karolinska Universitetssjukhuset
Solna, Stockholm County, Sweden, 171 64
2
HOPE
Stockholm, Sweden, 17176