Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369785
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2006-08-24
Brief Title:
Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Phase III Double Blind Placebo Controlled Study of Donepezil in the Irradiated Brain
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 may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors
PURPOSE This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors
PURPOSE This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors
Detailed Description:
OBJECTIVES
Primary
Compare the effect of donepezil hydrochloride vs placebo in terms of improving neurocognitive symptom cluster ie cognitive impairment subjective confusion and fatigue in patients who have undergone partial- or whole-brain irradiation for brain tumors
Secondary
Compare the effect of these regimens on mood and quality of life in these patients
OUTLINE This is a prospective double-blind placebo-controlled randomized multicenter study Patients are stratified according to prior brain irradiation type whole-brain vs partial-brain and study site Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral donepezil hydrochloride once or twice daily for up to 24 weeks in the absence of unacceptable toxicity
Arm II Patients receive oral placebo once or twice daily for up to 24 weeks in the absence of unacceptable toxicity
Patients complete self-reported questionnaires quality of life fatigue subjective confusion neurocognitive battery and mood at baseline and 12 and 24 weeks
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Primary
Compare the effect of donepezil hydrochloride vs placebo in terms of improving neurocognitive symptom cluster ie cognitive impairment subjective confusion and fatigue in patients who have undergone partial- or whole-brain irradiation for brain tumors
Secondary
Compare the effect of these regimens on mood and quality of life in these patients
OUTLINE This is a prospective double-blind placebo-controlled randomized multicenter study Patients are stratified according to prior brain irradiation type whole-brain vs partial-brain and study site Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral donepezil hydrochloride once or twice daily for up to 24 weeks in the absence of unacceptable toxicity
Arm II Patients receive oral placebo once or twice daily for up to 24 weeks in the absence of unacceptable toxicity
Patients complete self-reported questionnaires quality of life fatigue subjective confusion neurocognitive battery and mood at baseline and 12 and 24 weeks
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
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 |
|---|---|---|---|
| REBACCCWFU 91105 | OTHER | NCI | httpsreporternihgovquickSearchU10CA081851 |
| U10CA081851 | NIH | None | None |