Brain Metastases From Solid Tumors
Conditions
Interventions
Experimental group:Metformin: 500 mg orally, twice daily, starting no later than the third day after the initiation of Whole-Brain Radiotherapy, continued for 24 weeks.
Whole-Brain Radiotherapy: Presc
Control group:Whole-Brain Radiotherapy: Prescription dose for Whole-Brain Radiotherapy (WBRT) is 30 Gy in 10 fractions, and for Prophylactic Cranial Irradiation (PCI) is 25 Gy in 10 fractions, or ind
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Histologically or cytologically confirmed solid malignancy meeting any of the following radiotherapy indications: (1) >=5 brain metastases (requiring whole-brain radiotherapy); (2) limited-stage small cell lung cancer (requiring prophylactic whole-brain radiotherapy); (3) small cell lung cancer with brain metastases (1-4 lesions); 3. ECOG Performance Status score = 18; 5. Adequate liver and renal function: Serum creatinine = 30 mL/min, Total bilirubin <= 2.5 mg/dL, BUN < 20 mg/dL; 6. No history of allergy to Metformin, and no history of alcohol or drug abuse; 7. No prior brain radiotherapy; 8. Capable of understanding and cooperating with the cognitive assessment procedures; 9. Voluntarily agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe baseline cognitive impairment (MoCA-B score = 1 seizure episode within the past 2 months); 4. History of psychiatric disorders or long-term use of psychiatric medications; 5. Recent (within 6 months) major cardiovascular events: myocardial infarction, unstable angina, congestive heart failure; 6. Pregnant or lactating women; 7. Inability to complete cognitive assessments (e.g., severe visual or hearing impairment, or insufficient language comprehension); 8. Concurrent participation in other interventional clinical trials that may affect cognitive function; 9. Active infection requiring intravenous antibiotic treatment; 10. Uncontrolled diabetes (fasting blood glucose > 10.0 mmol/L or HbA1c > 9.0%) or acute diabetic complications occurring within the past 3 months; 11. Expected survival of less than 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive decline at 4 months after radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial progression-free survival;Overall survival;Safety;Quality of Life (QOL);Other cognitive outcomes; | — |
Countries
China
Contacts
Public ContactLi Yan
West China Hospital, Sichuan University
Outcome results
None listed