Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lithium, Placebo.
- Who it may be relevant to
- Registry conditions: Cognitive Impairment, Cognitive Decline, Radiotherapy Side Effect, Radiotherapy; Complications. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Late-appearing cognitive side effects after brain radiotherapy is a potential disabling condition in pediatric brain tumor survivors. It can have profound negative effects on education, career options and quality of life. There is no current interventional drug treatment to prevent this intellectual impairment after brain tumor treatment.
Primary objective:
To assess the efficacy of lithium treatment (up to 7 years) after brain radiotherapy (both whole brain and focal) for central nervous system malignancy in preventing late-appearing cognitive processing speed impairment in children aged 5 or older.
Secondary objectives:
* To assess the efficacy of lithium treatment through evaluation of other neuropsychological/quality of life test scores. * To assess the efficacy of lithium treatment through evaluation of radiological findings after lithium treatment using Magnetic Resonance Imaging (MRI) of the brain.
Exploratory objectives:
To explore the feasibility, safety and tolerability of lithium treatment in this patient group, using side effect forms/adverse events (AE) reporting and laboratory measures.
Interventions
- Drug Lithium
Lithium sulphate, 42 mg (6 mmol lithium) - Drug Placebo
White round tablet, 10 mm. Identical to experimental drug (lithium)
Primary outcome measures
- Processing Speed Index (PSI) [Time frame: 2 years after start of study treatment]
Secondary outcome measures (12)
- Fractional anisotropy (FA) index [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Other Wechsler Intelligence scale scores (except PSI): [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Grooved pegboard [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Beery/Buktenica visual motor integration (VMI) [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Conner´s Continous Performance Test (CPT) III [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Delis-Kaplan Executive Function System Trail Making Test (D-KEFS TMT) [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWT), age 8 years and above. [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Nepsy II: Inhibition, Verbal Fluency, [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Pediatric QoL Inventory (PedsQL) [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- University of California Los Angeles (UCLA) 3-Item Loneliness Scale (ULS-3) [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Strengths and Difficulties Questionnaire (SDQ) [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
- Behavior Rating Inventory of Executive Function (BRIEF). [Time frame: Baseline (before treatment) - 5 years after start of study treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Sweden · 2 centers
- Karolinska Universitetssjukhuset — Solna
- HOPE — Stockholm
Identifiers
NCT: NCT06051240 · 2023-504071-24-00 · 2023-504071-24-00