Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176540
Status:
TERMINATED
Last Update Posted:
2011-05-17
First Post:
2005-09-12
Brief Title:
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Dextromethorphan may help relieve fatigue in patients with cancer
PURPOSE This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer
PURPOSE This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer
Detailed Description:
OBJECTIVES
Primary
Assess the effects of dextromethorphan hydrobromide in patients with cancer-related fatigue
Secondary
Correlate the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
OUTLINE This is a multicenter open-label pilot study
Patients receive oral dextromethorphan hydrobromide 3 times a day on days 1-7 Treatment repeats weekly for up to 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Assess the effects of dextromethorphan hydrobromide in patients with cancer-related fatigue
Secondary
Correlate the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
OUTLINE This is a multicenter open-label pilot study
Patients receive oral dextromethorphan hydrobromide 3 times a day on days 1-7 Treatment repeats weekly for up to 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 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 |
|---|---|---|---|
| CINJ-NJ11005 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |
| CINJ-5017v2 | None | None | None |
| CINJ-4598 | None | None | None |