Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217724
Status:
TERMINATED
Last Update Posted:
2017-05-09
First Post:
2005-09-20
Brief Title:
Glutamine in Preventing Myalgia andor Arthralgia in Patients Who Are Receiving Paclitaxel For Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Double-blinded Pilot Study of Glutamine for the Prevention of Paclitaxel-Induced Myalgias and Arthralgias
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only able to accrue just 18 of the 40 target funds were limited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as paclitaxel work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Nutritional supplements such as glutamine may prevent side effects caused by chemotherapy
PURPOSE This randomized clinical trial is studying glutamine to see how well it works compared to placebo in preventing myalgia andor arthralgia in patients who are receiving paclitaxel for cancer
PURPOSE This randomized clinical trial is studying glutamine to see how well it works compared to placebo in preventing myalgia andor arthralgia in patients who are receiving paclitaxel for cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of glutamine supplementation vs placebo in terms of prevention of paclitaxel-induced myalgia andor arthralgia in patients with cancer
Secondary
Compare the attenuation of myalgia andor arthralgia in patients who experience myalgia andor arthralgia treated with these regimens
OUTLINE This is a randomized double-blind crossover pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Beginning on day 2 of course 1 of paclitaxel administration patients receive oral glutamine three times daily for 4 days
Arm II Beginning on day 2 of course 1 of paclitaxel administration patients receive oral placebo three times daily for 4 days
Both arms crossover during course 2 In both arms treatment continues in the absence of unacceptable toxicity
After completion of study treatment patients are followed for 7-10 days
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Compare the efficacy of glutamine supplementation vs placebo in terms of prevention of paclitaxel-induced myalgia andor arthralgia in patients with cancer
Secondary
Compare the attenuation of myalgia andor arthralgia in patients who experience myalgia andor arthralgia treated with these regimens
OUTLINE This is a randomized double-blind crossover pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Beginning on day 2 of course 1 of paclitaxel administration patients receive oral glutamine three times daily for 4 days
Arm II Beginning on day 2 of course 1 of paclitaxel administration patients receive oral placebo three times daily for 4 days
Both arms crossover during course 2 In both arms treatment continues in the absence of unacceptable toxicity
After completion of study treatment patients are followed for 7-10 days
PROJECTED ACCRUAL A total of 40 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 |
|---|---|---|---|
| 1252 | OTHER | OHSU IRB | None |
| OHSU-ONC-99037-L | OTHER | None | None |