Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070161
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2003-10-03
Brief Title:
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Donepezil and EGb761 may be effective in improving neurocognitive function such as thinking attention concentration and memory and may improve quality of life in patients who have undergone radiation therapy to the brain
PURPOSE This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases
PURPOSE This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases
Detailed Description:
OBJECTIVES
Primary
Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration
Secondary
Determine the toxicity of these drugs in these patients
Determine the quality of life of patients treated with these drugs
Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs
OUTLINE This is an open-label multicenter study
Group 1 closed to accrual 100903 Patients receive oral donepezil once daily for 24 weeks
Group 2 Patients receive oral EGb761 three times daily for 24 weeks In both groups group 1 closed to accrual 100903 treatment continues in the absence of unacceptable toxicity
In both groups group 1 closed to accrual 100903 quality of life and neurocognitive assessment is performed at baseline and at weeks 6 group 1 only 12 24 and 30
Patients are followed at 6 weeks
PROJECTED ACCRUAL A total of 70 patients 35 per treatment group will be accrued for this study within 95 months Group 1 closed to accrual 100903
Primary
Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration
Secondary
Determine the toxicity of these drugs in these patients
Determine the quality of life of patients treated with these drugs
Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs
OUTLINE This is an open-label multicenter study
Group 1 closed to accrual 100903 Patients receive oral donepezil once daily for 24 weeks
Group 2 Patients receive oral EGb761 three times daily for 24 weeks In both groups group 1 closed to accrual 100903 treatment continues in the absence of unacceptable toxicity
In both groups group 1 closed to accrual 100903 quality of life and neurocognitive assessment is performed at baseline and at weeks 6 group 1 only 12 24 and 30
Patients are followed at 6 weeks
PROJECTED ACCRUAL A total of 70 patients 35 per treatment group will be accrued for this study within 95 months Group 1 closed to accrual 100903
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA081851 | NIH | None | httpsreporternihgovquickSearchU10CA081851 |