Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052286
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-01-24
Brief Title:
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
Status:
COMPLETED
Status Verified Date:
2016-02
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 Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known
PURPOSE This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer
PURPOSE This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer
Detailed Description:
OBJECTIVES
Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors
Determine the safety of this drug in these patients
Compare quality of life of patients treated with 2 different doses of this drug
OUTLINE This is a randomized double-blind parallel-group study Patients are randomized to 1 of 2 arms
Randomized phase
Arm I Patients receive oral high-dose modafinil twice daily
Arm II Patients receive oral low-dose modafinil twice daily In both arms treatment in this phase continues for 3 weeks followed by a 1-week washout period
Extended treatment phaseAfter the 1-week washout period all patients receive oral low-dose modafinil once daily on days 1-3 The dose is then titrated to an optimal level and administered in divided doses
Fatigue neurobehavioral dysfunction and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors
Determine the safety of this drug in these patients
Compare quality of life of patients treated with 2 different doses of this drug
OUTLINE This is a randomized double-blind parallel-group study Patients are randomized to 1 of 2 arms
Randomized phase
Arm I Patients receive oral high-dose modafinil twice daily
Arm II Patients receive oral low-dose modafinil twice daily In both arms treatment in this phase continues for 3 weeks followed by a 1-week washout period
Extended treatment phaseAfter the 1-week washout period all patients receive oral low-dose modafinil once daily on days 1-3 The dose is then titrated to an optimal level and administered in divided doses
Fatigue neurobehavioral dysfunction and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| UCLA-0206017 | None | None | None |
| CEPHALON-UCLA-0206017 | None | None | None |
| NCI-G02-2133 | None | None | None |