Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112515
Status:
UNKNOWN
Last Update Posted:
2009-08-20
First Post:
2005-06-02
Brief Title:
Modafinil in Treating Fatigue in Patients With Cancer
Sponsor:
University of Virginia
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue Mood Cognitive Ability Functional Status and Quality of Life of Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 help relieve fatigue and improve quality of life in patients with cancer
PURPOSE This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer
PURPOSE This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of modafinil in cancer patients
Determine the efficacy of this drug in terms of improving fatigue in these patients
Secondary
Determine the efficacy of this drug in terms of improving mood cognitive ability functional status and quality of life in these patients
OUTLINE This is a nonrandomized pilot study
Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity Patients may receive additional modafinil at the discretion of the physician
Fatigue mood cognition functional status and quality of life are assessed at baseline and in weeks 2 and 4
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 26 patients will be accrued for this study within 9 months
Primary
Determine the safety of modafinil in cancer patients
Determine the efficacy of this drug in terms of improving fatigue in these patients
Secondary
Determine the efficacy of this drug in terms of improving mood cognitive ability functional status and quality of life in these patients
OUTLINE This is a nonrandomized pilot study
Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity Patients may receive additional modafinil at the discretion of the physician
Fatigue mood cognition functional status and quality of life are assessed at baseline and in weeks 2 and 4
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 26 patients will be accrued for this study within 9 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UVACC-HIC-10951 | None | None | None |
| UVACC-30603 | None | None | None |