Actively Recruiting
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy in Pediatric Brain Tumor Survivors
Led by Region Stockholm · Updated on 2024-04-12
84
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
R
Region Stockholm
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether taking oral lithium tablets for six months can help prevent cognitive decline in children who have undergone brain radiotherapy for brain tumors. This randomized, placebo-controlled, double-blinded study focuses on pediatric brain tumor survivors aged 5 years and older, investigating the effect of lithium on cognitive processing speed measured two years after starting treatment. Participants will receive either lithium sulphate tablets or identical placebo tablets. The lithium dose starts at 42 mg once daily and is gradually increased to maintain a target blood level between 0.5 and 1.0 mmol/l, using therapeutic drug monitoring. Placebo dosing follows a similar schedule with sham monitoring. The study treatment lasts for up to seven years, including ongoing evaluation of cognitive function and brain imaging. During the study, participants will undergo regular neuropsychological tests, quality of life assessments, and brain MRI scans from baseline through up to five years after treatment begins. Researchers will monitor side effects and laboratory tests to assess safety and tolerability. The main outcome measured is the Processing Speed Index two years after treatment starts, with additional cognitive and behavioral tests conducted over the longer term. Participant involvement includes scheduled visits and assessments during and after treatment to monitor cognitive health and overall well-being.
CONDITIONS
Brief Title
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 5 years
- Age less than 18 years at time of radiotherapy
- Received cranial or craniospinal radiation treatment for brain tumor within the last 7 years
- Using an adequate contraceptive method to prevent pregnancy during lithium treatment and for six months after
- Negative pregnancy test at screening, start of treatment, and monthly thereafter
- Written informed consent from patient and/or caregiver
You will not qualify if you...
- Allergy or hypersensitivity to lithium or any ingredients
- Renal failure with Glomerular Filtration Rate less than 60
- Cardiac failure or heart disease, including Brugada syndrome or family history
- Uncontrolled hypothyroidism
- Pregnancy or breastfeeding
- Severe fluid or electrolyte imbalance
- Karnofsky-Lansky score less than 60
- Other serious conditions making study participation unsuitable (such as low survival prognosis, poor compliance, inability to swallow tablets, or language difficulties)
- Participation in another study that conflicts with this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 years
Participants receive lithium or placebo treatment with dose escalation and therapeutic drug monitoring to maintain target serum levels. Treatment aims to prevent cognitive impairment after brain radiotherapy.
Monthly visits during treatment for monitoring and assessments
Duration - Up to 5 years after start of treatment
Participants undergo long-term neuropsychological and radiological evaluations to assess cognitive function and brain imaging outcomes after treatment.
Regular assessments as scheduled during treatment and follow-up period
Trial Site Locations
Total: 2 locations
1
Karolinska Universitetssjukhuset
Solna, Stockholm County, Sweden, 171 64
Not Yet Recruiting
2
HOPE
Stockholm, Sweden, 17176
Actively Recruiting
Research Team
K
Klas Blomgren, MD, Professor
G
Gustaf Hellspong, MD, PhD Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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