Actively Recruiting
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
Led by Region Stockholm · Updated on 2024-04-12
84
Participants Needed
2
Research Sites
497 weeks
Total Duration
On this page
Sponsors
R
Region Stockholm
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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
- Use of adequate contraceptive methods to prevent pregnancy during lithium treatment and for six months after
- Negative pregnancy test at screening, start of study treatment, and monthly during treatment
- Written informed consent from patient and/or caregiver
You will not qualify if you...
- Allergy or hypersensitivity to lithium or any excipients
- 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 conditions incompatible with study inclusion such as poor survival prognosis, poor protocol compliance, inability to swallow tablets, or language difficulties
- Participation in another study that prevents inclusion in this trial
AI-Screening
AI-Powered Screening
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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
CONTACT
G
Gustaf Hellspong, MD, PhD Student
CONTACT
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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