MET-MED Study

Project status: Active

Research area: Clinical Sciences > Brain and Mind

This study is seeking to understand if a drug called Metformin can be used to improve thinking skills and promote white matter growth in children that have been previously treated for medulloblastoma.

Why are we doing this research study?

While we know that our treatments for childhood brain cancer are very good at curing the disease, they can also, unfortunately, cause long-term changes in brain tissue and thinking skills (called cognitive late effects). Such late effects can negatively impact a young person's long-term academic, vocational and social outcomes.

MET-MED is a Phase 3 Randomised Double-Blind, Placebo-Controlled Trial of Metformin for Cognitive Recovery and White Matter Growth in Paediatric Medulloblastoma Patients.

What is Medulloblastoma? - The Royal Children's Hospital

Information for participants

Who can participate?

We are recruiting children and young people who are:

Finished primary therapy for medulloblastoma and medically stable
Aged 7 to 17 years
Proficient in English

What happens during the study?

Taking part in this study will take 41 weeks in total and has four different phases, outlined below.

Screening and baseline assessments:
1. Height and weight checks
2. Blood tests
3. Thinking skills tests and questionnaire
4. MRI brain scan (no contrast)
16 weeks of taking medication
Post-intervention assessments (same as baseline)
6-month follow-up assessment (same as baseline)

Throughout the duration of the study, children have regular medical check-ups, five of these will be in-person at The Royal Children's Hospital (RCH) Melbourne, and four will be via telehealth or phone.

Important note: This is a double-blind randomised control trial, this means children will be randomly assigned to receive Metformin or a Placebo tablet. Neither you nor the study team will know which group your child is in.

More about the MET-MED Study

What are the potential side effects?

Metformin is approved by the Therapeutic Goods Administration (TGA) Australia to treat diabetes. However, it is not approved to treat children/young adults after treatment for medulloblastoma to improve thinking. All study medications may cause some side effects or other reactions.

Metformin may affect how different parts of the body work such as the liver, kidneys, heart, and blood. The most common side effect (up to 20 people in 100) is diarrhoea. There are also some occasional (up to 5 people in 100) and rare (up to 1 people in 100) side effects that will be further discussed with you by medical team members, should you wish to find out more information please contact us.

How to get involved?

We hope that this project will help us work towards improving some of the cognitive late effects experienced by children and young people treated for medulloblastoma. To register or find out more information on the MET-MED Study, please contact us below.