Lithium Tablets to Prevent Cognitive Decline After Brain Radiotherapy
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
Recruiting
Phase 2Interventional Study
Cognitive ImpairmentCognitive DeclineRadiotherapy Side EffectRadiotherapy; ComplicationsBrain TumorMemory ImpairmentLate Effect of Radiation
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
5 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
84 (estimated)
Sponsor
Region Stockholm · Government
Who this trial is looking for
This trial is looking for young survivors of brain tumors who have received radiation treatment. Participants will take lithium tablets for 6 months to see if it helps with thinking skills.
Are You a Good Fit for This Trial?
You may be able to join if
I am older than 5 years.
I am younger than 18 years when I had radiotherapy.
I had radiation for a brain tumor in the last 7 years.
I can use a reliable contraceptive method during the treatment.
I had a negative pregnancy test before starting the study.
I or my caregiver can give written consent to participate.
You may not be able to join if
I am allergic to lithium or any of its ingredients.
I have kidney failure.
I have heart disease.
I have untreated hypothyroidism.
I am pregnant or breastfeeding.
I have a severe fluid or electrolyte imbalance.
My Karnofsky-Lansky score is below 60.
I am part of another study that does not allow me to join this one.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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.…
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.
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