Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064272
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2003-07-08
Brief Title:
UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
Status:
COMPLETED
Status Verified Date:
2016-10
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:
IRB 2003-551
Brief Summary:
RATIONALE The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer
PURPOSE This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer
PURPOSE This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer
Detailed Description:
OBJECTIVES
Primary
Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo
Secondary
Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens
Compare the safety of these regimens in these patients
Determine whether patients can determine if they are receiving placebo or study drug and by which variable eg taste smell or decrease in nausea and vomiting
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 3 treatment arms Patients are stratified according to concurrent antiemetic type 5-HT_3 antagonist vs NK1 antagonist
Arm I Patients receive lower-dose oral ginger twice daily
Arm II Patients receive higher-dose oral ginger twice daily
Arm III Patients receive oral placebo twice daily In all arms treatment begins immediately after the chemotherapy treatment and continues for 3 days
Patients are followed at 1 week
PROJECTED ACCRUAL A total of 180 patients 60 per treatment arm will be accrued for this study
Primary
Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo
Secondary
Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens
Compare the safety of these regimens in these patients
Determine whether patients can determine if they are receiving placebo or study drug and by which variable eg taste smell or decrease in nausea and vomiting
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 3 treatment arms Patients are stratified according to concurrent antiemetic type 5-HT_3 antagonist vs NK1 antagonist
Arm I Patients receive lower-dose oral ginger twice daily
Arm II Patients receive higher-dose oral ginger twice daily
Arm III Patients receive oral placebo twice daily In all arms treatment begins immediately after the chemotherapy treatment and continues for 3 days
Patients are followed at 1 week
PROJECTED ACCRUAL A total of 180 patients 60 per treatment arm 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 |
|---|---|---|---|
| CCUM-0201 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA046592 |
| P30CA046592 | NIH | None | None |