Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Cognitive Impairment, Cognitive Decline, Radiotherapy Side Effect, Radiotherapy; Complications, Brain Tumor, Memory Impairment, Late Effect of Radiation
In brief
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.
Key facts
- Study ID
- NCT06051240
- Run by
- Region Stockholm
- People needed
- 84
- Starts
- 2024-02-16
- Expected to finish
- 2033-08-31
- Last updated by the study team
- 2024-04-12
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- HOPE — Stockholm, Sweden (enrolling)
- Karolinska Universitetssjukhuset — Solna, Stockholm County, Sweden
Full record on ClinicalTrials.gov
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