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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.
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 twice per day, for at least 6 weeks and up to 6 months for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver.
Patients who have been diagnosed with a primary brain tumor and who have been prescribed levetiracetam will be prescribed 100 mg of Vitamin B6 as a supplement to take daily in the morning, by mouth for 8 to 12 weeks, in addition to the already prescribed levetiracetam. Patients will undergo study assessments and will complete self-reported questionnaires to evaluate their mood at two different timepoints: one after patient enrollment and the second at the follow-up visit scheduled about 8 to 12 weeks after initiation of VitB6 supplementation .
Additionally, each patient will be asked to identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes at the same time interval as the patient. A caregiver can include any person identified by the patient who is directly involved in their care and support. This includes, but is not limited to, assisting with daily living, meal preparation, transportation, medication management, financial support, coordinating health appointments, and promoting emotional well-being. The identification of a caregiver is optional and is not a requirement for patient participation.
After the patient and their caregiver complete their respective questionnaires, the study will end. Patients may choose to either continue or discontinue taking VitB6 after the study ends.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B6 supplementation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B6 100 MG | Dietary Supplement | Patients will be prescribed 100 mg of Vitamin B6 as a supplement to take daily in the morning, by mouth for 8 to 12 weeks, in addition to the already prescribed levetiracetam. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of VitB6 supplementation on LEV-associated mood changes in patients with BTRE, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anger questionnaire | Mean change in patient-reported PROMIS anger T-scores between baseline and the 8 to 12-week follow-up visit among patients who complete questionnaires at both timepoints. Each item on the PROMIS Anger Short Form is rated on a 5-point scale. The total score can range from 5 to 25, with higher scores indicating greater severity of anger. | From enrollment (Baseline) to follow-up at 8-12 weeks from the initiation of VitB6 supplementation |
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Inclusion Criteria for Patients:
Inclusion Criteria for Caregivers:
Exclusion Criteria for Patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Peters, MD, PhD | Contact | 919-684-5301 | dukebrain1@duke.edu | |
| Stevie Threatt, MS | Contact | 919-684-5301 | dukebrain1@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katherine Peters, MD, PhD | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D025101 | Vitamin B 6 |
| ID | Term |
|---|---|
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |