B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
This is a supportive care study to assess the effect of Vitamin B6 supplementation on mood-related side effects of levetiracetam in patients with brain tumors, who have already been prescribed levetiracetam for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver. Patients will receive Vitamin B6 as a supplement to take daily for 8 to 12 weeks, in addition to the already prescribed levetiracetam and will undergo study assessments as well as complete self-reported questionnaires to evaluate their mood during the course of the study. Additionally, each patient will be asked to optionally identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes, at the same time interval as the patient.
• Age ≥ 18 years
• Diagnosed with a primary brain tumor
• Karnofsky Performance Status ≥ 70%
• Have one or more documented seizures or transient events concerning for localization-related epilepsy requiring anti-seizure medication prophylaxis
• Have an active immediate release levetiracetam prescription
• Taking levetiracetam for ≥ 6 weeks and ≤ 6 months before screening
• Baseline patient-reported mood symptoms and/or National Comprehensive Cancer Network distress thermometer score ≥ 3
• Has access to e-mail where they can receive electronic informed consent form (ICF) and questionnaires
• Signed ICF approved by the institutional review board (IRB)
• Age ≥ 18 years
• Patient has indicated that it is acceptable to recruit their caregivers into the study
• Able to read and write English
• Has access to e-mail where they can receive electronic ICF and questionnaires
• Signed ICF approved by the IRB