Ensayos clínicos

Inclusion Criteria: 

• Age ≥ 18 years.
• Diagnosis of brain tumor requiring cranial radiation treatment;
  • NOTE: Patient may be enrolled during or up to 3 years after completion of cranial radiation administered for treatment of primary or metastatic intracranial tumor
• ECOG Performance Status of 0, 1, or 2, AND Karnofsky Performance Status (KPS) of ≥ 70 (Appendix I).
• Expected survival ≥ 6 months in the opinion of treatment team.
• Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations.
• The following laboratory values obtained ≤30 days prior to registration:
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with baseline liver disease).
• Negative pregnancy test ≤8 days prior to registration for persons of childbearing potential only.
• Ability to complete cognitive assessments and questionnaires by themselves or with assistance.

Exclusion Criteria:

• Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings.
• Pregnant or nursing, imprisoned, or lacking capacity for understanding.
• Unable to swallow tablets or at risk for impaired absorption of oral medication.
• Currently taking the study agent (i.e., metformin), and cannot safely discontinue if randomized to the control group (Group B).
• Known hypersensitivity or allergy to metformin.
• Current use of resveratrol, CoQ10 (coenzyme Q10), coconut oil/other medium chain triglyceride-containing (e.g., Axona) supplements, or curcumin and unwilling to discontinue prior to registration and remain off these agents for study duration.
• Unable to read and speak English. Note: English doses not to need to be primary language.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/29/23. Questions regarding updates should be directed to the study team contact.