Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042848
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2002-08-05
Brief Title:
Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
Phase III Randomized Placebo-Controlled Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-10
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 in patients with cancer who are undergoing chemotherapy The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known
PURPOSE This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer
PURPOSE This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer
Detailed Description:
OBJECTIVES
Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy
Assess the relationship between depression and fatigue in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Beginning on day 5 of the second course of chemotherapy patients receive oral modafinil once daily
Arm II Beginning on day 5 of the second course of chemotherapy patients receive oral placebo once daily
Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of disease progression or unacceptable toxicity
Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy
PROJECTED ACCRUAL A total of 837 patients will be accrued for this study within approximately 25 years
Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy
Assess the relationship between depression and fatigue in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Beginning on day 5 of the second course of chemotherapy patients receive oral modafinil once daily
Arm II Beginning on day 5 of the second course of chemotherapy patients receive oral placebo once daily
Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of disease progression or unacceptable toxicity
Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy
PROJECTED ACCRUAL A total of 837 patients will be accrued for this study within approximately 25 years
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 |
|---|---|---|---|
| U10CA037420 | NIH | None | None |
| URCC-U2901 | OTHER | University of Rochester | httpsreporternihgovquickSearchU10CA037420 |