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ClinicalTrials.gov ID

NCT06051240

Lead Sponsor

Region StockholmOTHER_GOV

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

84Estimated

Last Update Posted

Apr 12, 2024Actual

Start Date

Feb 16, 2024Actual

Primary Completion Date

Aug 31, 2030Estimated

Completion Date

Aug 31, 2033Estimated

Official Title

Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Brief Summary

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.

• Cognitive Impairment
• Cognitive Decline
• Radiotherapy Side Effect
• Radiotherapy; Complications
• Brain Tumor
• Memory Impairment
• Late Effect of Radiation

• Lithium
• Placebo

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Region StockholmOTHER_GOV

Collaborators

Rigshospitalet, DenmarkOTHER

gustaf.hellspong@regionstockholm.se+46812371594