Tests lithium to help prevent memory and thinking decline after brain radiotherapy
Tests lithium tablets against placebo in children with brain tumors after radiotherapy.
Plain-language title generated from the registry record
Registry title: Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
Key facts
- Where
- Aalborg, Aarhus N, Copenhagen Oe, and Odense C, DenmarkSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 64 years old?
Source: NCT06051240, who can take part
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus UniversitetshospitalAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Stockholm
- Trial code
- NCT06051240EU 2023-504071-24-00
- Record updated
- 12 April 2024
- Original description
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.Read full original descriptionShow less
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
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.
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); 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); Uncontrolled hypothyroidism; Pregnancy or breast feeding; Severe fluid or electrolyte imbalance; Karnofsky-Lansky score < 60; Inclusion in other study protocol precluding inclusion in this study.