Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Sponsor
Region Stockholm
Study ID
NCT06051240
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lithium — DRUG
    Lithium sulphate, 42 mg (6 mmol lithium)
  • Placebo — DRUG
    White round tablet, 10 mm. Identical to experimental drug (lithium)

Study Details

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.

Key Dates

First listed
Sep 22, 2023
Start date
Feb 16, 2024
Status verified
Jun 2023
Primary completion
Aug 31, 2030
Completion
Aug 31, 2033

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Processing Speed Index (PSI) [ Time Frame: 2 years after start of study treatment ]

Central Contacts

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