Medulloblastoma after comprehensive treatment
Conditions
Interventions
Treatment Group A:Taking metformin
Treatment Group B:Take the placebo
Sponsors
Shenzhen Children’s Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Age: 5~18 years old, the treatment of the primary disease has been completed; 2.Diagnosed with intracranial medulloblastoma, the standard treatment plan has been completed (surgery + whole central nervous system radiotherapy + maintenance chemotherapy), and the primary disease is currently in a complete response state (CR); 3.The time from the start of whole central nervous system radiotherapy to the start of this clinical trial shall not exceed 15 years; 4.Patients with ventriculoperitoneal shunts can also be included in the trial, but need to be confirmed before enrollment regarding imaging-related considerations; 5.Certain level of organ function: a) adequate kidney function, defined as creatinine clearance or GFR measured by radioisotope > 70ml/min/1.73m^2; b) adequate liver function: i. total bilirubin < 1.5 times the upper limit of normal (ULN) for age, ii. SGOT (AST) or SGPT (ALT) < 3 times the upper limit of normal (ULN) for age; 6.The pregnancy test results for women of childbearing potential must be negative, and they agree to use medically acceptable contraception during the entire study period and for 30 days after the last dose of the study drug; 7.Obtain written informed consent from the patient and/or their legal guardian.
Exclusion criteria
Exclusion criteria: 1.Brain tumor patients receiving palliative care treatment; 2.Those who cannot complete neuroimaging examinations without sedatives; 3.Those who cannot take oral tablets; 4.Patients with unstable and/or insulin-dependent (Type 1) diabetes mellitus; 5.Patients with acute or chronic metabolic acidosis and/or lactic acidosis; 6.with a history of renal disease or renal impairment (e.g., elevated serum creatinine or abnormal creatinine clearance); 7.A history of congestive heart failure requiring medication; 8.Known allergy to metformin hydrochloride;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuroimaging measurement results; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wechsler Intelligence Test Scale;Arterial spin marking; | — |
Countries
China
Contacts
Public ContactSixi Liu
Shenzhen Children’s Hospital
Outcome results
None listed