Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2033-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization is based on whether or not the study participant had received radiotherapy to the whole brain (CSI) or only part of it (focal irradiation). Within each of these two arms there is a predetermined block randomization with a 2:1 lithium:placebo ratio.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Identical-looking placebo is used. S-lithium levels are masked by using a separate lab service and sham values for placebo group.

Study Groups

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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.

Group Type EXPERIMENTAL

Lithium

Intervention Type DRUG

Lithium sulphate, 42 mg (6 mmol lithium)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Lithium

Lithium sulphate, 42 mg (6 mmol lithium)

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Lithionit Lithium sulphate

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No