Clinical trial · Interventional
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
NCT06051240CI-TRIAL-00075958LiBRArecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Cognitive Decline | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Late Effect of Radiation | — | UNRESOLVED | — |
| Memory Impairment | — | UNRESOLVED | — |
| Radiotherapy; Complications | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lithium | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lithium
- description
- Lithionit 42 mg (lithium sulphate, 6 mmol), start dose 1x1, then slow dose escalation using therapeutic drug monitoring (TDI) to establish a target serum level of 0.5-1.0 mmol/liter.
- interventionNames
- Drug: Lithium
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Identical looking placebo (white round tablet, 10 mm diameter) will be dose escalated and monitored the same way as lithium, with sham values guiding the dosing.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Processing Speed Index (PSI)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.