Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

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Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	5 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06051240
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Region Stockholm
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cognitive Impairment, Cognitive Decline, Radiotherapy Side Effect, Radiotherapy; Complications, Brain Tumor, Memory Impairment, Late Effect of Radiation

Additional Details

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.

Arms & Interventions

Arms

Experimental: Lithium

Lithionit 42 mg (lithium sulphate, 6 mmol), start dose 1x1, then slow dose escalation using therapeutic drug monitoring (TDI) to establish a target serum level of 0.5-1.0 mmol/liter.

Placebo Comparator: Placebo

Identical looking placebo (white round tablet, 10 mm diameter) will be dose escalated and monitored the same way as lithium, with sham values guiding the dosing.

Interventions

Drug: - Lithium

Lithium sulphate, 42 mg (6 mmol lithium)

Drug: - Placebo

White round tablet, 10 mm. Identical to experimental drug (lithium)

Contact a Trial Team

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