Study on Lithium Sulphate to Prevent Cognitive Impairment in Children After Brain Tumor Radiotherapy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Lithionit, which contains the active ingredient lithium sulphate. The study is aimed at children who have undergone brain radiotherapy for a brain tumor. The purpose of the study is to see if Lithionit can help prevent problems with thinking and processing information that might appear after such treatment.

Participants in the study will receive either Lithionit or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for several years, with regular check-ups to monitor the participants’ cognitive abilities, which means their ability to think, learn, and remember. These check-ups will include various tests to measure different aspects of brain function, such as processing speed and memory. The study will also use MRI scans to look at changes in the brain over time.

The goal is to understand if Lithionit can help maintain or improve cognitive function in children who have had brain radiotherapy. This research is important because it could lead to better treatments for preventing cognitive issues in young patients who have received such treatments for brain tumors.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate in the study after understanding all the details and potential risks involved.

2 initial assessments

You will undergo a series of initial assessments to establish a baseline. These assessments will include tests to measure your Processing Speed Index (PSI) and other cognitive functions. These tests are designed to evaluate your current cognitive abilities before starting the treatment.

3 start of treatment

You will begin taking the study medication, which is a prolonged-release tablet containing lithium sulphate. The dosage is 42 mg, and it is taken orally. The frequency and duration of the medication will be specified by the study team.

4 regular follow-up assessments

Throughout the study, you will have regular follow-up assessments to monitor your cognitive functions. These assessments will occur approximately at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after starting the treatment. The tests will include various cognitive and neuropsychological evaluations.

5 ongoing monitoring

Your health and any side effects from the medication will be closely monitored throughout the study. This includes regular check-ups and possibly additional tests to ensure your safety and well-being.

6 end of study assessments

At the end of the study period, which is estimated to be in 2033, you will undergo final assessments to evaluate any changes in your cognitive functions compared to the baseline measurements taken at the start of the study.

Who Can Join the Study?

Age must be 5 years or older.
Age must be less than 18 years at the time of receiving radiotherapy.
Must have received cranial/craniospinal radiation treatment for a brain tumor within the last 7 years. Cranial/craniospinal radiation is a type of treatment that uses high-energy rays to target the brain and spine.
Must use adequate contraception to prevent pregnancy during the entire period of lithium treatment and for six months after the treatment ends.
Must have a negative pregnancy test at the start of the study and every month during the study.
Must provide written informed consent from the patient and/or caregiver. This means agreeing to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients with a brain tumor cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Region Oestergoetland	Linkoping	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Odense University Hospital	Odense	Denmark
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Norrlands University Hospital	Umea	Sweden
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Uorfwlz Umdtjdajjq Hstdpghc	Uppsala	Sweden
Afvddv Uwxgnruwgi Hicinsqr	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2023
Sweden	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Lithium Sulphate, Anhydrous

Lithium is a medication that is being tested in this clinical trial to see if it can help protect the brain after radiotherapy, which is a type of treatment that uses high-energy rays to kill cancer cells. The trial is focused on children who have had radiotherapy for brain cancer. Researchers want to find out if lithium can prevent problems with thinking and processing information that might appear later on after the treatment. Lithium is commonly used to treat mood disorders, but in this study, it is being explored for its potential to protect brain function.

Brain tumor – A brain tumor is an abnormal growth of cells within the brain or central spinal canal. These tumors can be either benign (non-cancerous) or malignant (cancerous). As the tumor grows, it can cause increased pressure inside the skull, leading to symptoms such as headaches, nausea, and changes in behavior or cognitive function. The progression of a brain tumor depends on its type, location, and growth rate. Some tumors may grow slowly and cause minimal symptoms for a long time, while others can grow rapidly and affect brain function more quickly. The impact on the brain can lead to various neurological symptoms, depending on the areas of the brain involved.

Trial ID:

2023-504071-24-00

Protocol code:

LiBRA

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Lithium Sulphate to Prevent Cognitive Impairment in Children After Brain Tumor Radiotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?