Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Last updated: April 11, 2024
Sponsor: Region Stockholm
Overall Status: Active - Recruiting

Phase

2

Condition

Brain Tumor

Alzheimer's Disease

Astrocytoma

Treatment

Placebo

Lithium

Clinical Study ID

NCT06051240
2023-504071-24-00
2023-504071-24-00
  • Ages > 5
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >5 years.
  • Age <18 years at time of radiotherapy.
  • Has received cranial/craniospinal radiation treatment of brain tumor within the last 7years.
  • Adequate contraceptive method to prevent pregnancy* during the entire lithiumtreatment period and six months thereafter.
  • Negative pregnancy test* at screening, at start of study treatment, and monthlythereafter.
  • Written informed consent from patient and/or caregiver.

Exclusion

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 historythereof).
  • 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 yearsurvival prognosis less than 25 %, expected poor protocol compliance, inability toswallow tablets, language difficulties).
  • Inclusion in other study protocol precluding inclusion in this study.

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 16, 2024
Estimated Completion Date:
August 31, 2033

Study 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.

Connect with a study center

  • Karolinska Universitetssjukhuset

    Solna, Stockholm 171 64
    Sweden

    Site Not Available

  • HOPE

    Stockholm, 17176
    Sweden

    Active - Recruiting

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