Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy

Launched by REGION STOCKHOLM · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called lithium can help prevent memory problems in children and young adults who have received radiation treatment for brain tumors. The researchers want to see if taking lithium tablets for six months can protect the brain from cognitive decline, which means a decrease in thinking skills, after undergoing radiotherapy. The main goal is to measure how well participants can process information two years after starting the treatment.

To be eligible for this trial, participants must be between 5 and 18 years old and have received radiation therapy for a brain tumor within the last seven years. They also need to agree to use effective birth control during the study, as lithium can affect pregnancy. Participants will be randomly assigned to either receive lithium or a placebo (a look-alike pill with no active medication) for six months. Throughout the study, they will have regular check-ups to monitor their health and ensure the treatment is safe. This trial is currently recruiting participants, and it aims to provide valuable insights into how to support brain health in young survivors of brain cancer.

Gender

ALL

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.