Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040742
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2002-07-08
Brief Title:
Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
A Phase IIIII Randomized Controlled Clinical Trial Of Ginger Zingiber Officinale For Nausea Caused By Chemotherapy For Cancer
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 Ginger may help reduce or prevent nausea It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy
PURPOSE This randomized phase IIIII trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer
PURPOSE This randomized phase IIIII trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of 1 course of ginger vs placebo when administered in regimens containing a 5-hydroxytryptamine type 3 5-HT3 receptor antagonist antiemetic and dexamethasone or the equivalent dose of IV methylprednisolone in controlling chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer
Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related nausea in these patients
Determine the adverse effects of ginger when given 3 days before chemotherapy administration in these patients
Determine the adverse effects of these antiemetic regimens during the 4 days after chemotherapy
Compare the chemotherapy-related anticipatory nausea in patients treated with these antiemetic regimens
Compare the quality of life during the 4 days after chemotherapy in patients treated with these antiemetic regimens
Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients after 2 courses of ginger vs placebo
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 4 treatment arms Day 1 of each course is defined as the day of chemotherapy administration
Placebo Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3
05g Ginger Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3
10g Ginger Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3
15g Ginger Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3
Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a 5-hydroxytryptamine type-3 5-HT3 receptor antagonist ondansetron granisetron tropisetron and dolasetron mesylate and dexamethasone DM or the equivalent dose of IV methylprednisolone MePRDL on day 1 of courses 2 and 3
Symptoms are assessed on day -3 to day 1 of courses 2 and 3 and on days 1-4 of courses 1-3
Quality of life is assessed on day 4 of courses 1-3
Nausea and vomiting are assessed 4 times daily on days 1-4 of courses 1-3
PROJECTED ACCRUAL A total of 706 patients will be accrued for this study within 3 years
Compare the efficacy of 1 course of ginger vs placebo when administered in regimens containing a 5-hydroxytryptamine type 3 5-HT3 receptor antagonist antiemetic and dexamethasone or the equivalent dose of IV methylprednisolone in controlling chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer
Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related nausea in these patients
Determine the adverse effects of ginger when given 3 days before chemotherapy administration in these patients
Determine the adverse effects of these antiemetic regimens during the 4 days after chemotherapy
Compare the chemotherapy-related anticipatory nausea in patients treated with these antiemetic regimens
Compare the quality of life during the 4 days after chemotherapy in patients treated with these antiemetic regimens
Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients after 2 courses of ginger vs placebo
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 4 treatment arms Day 1 of each course is defined as the day of chemotherapy administration
Placebo Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3
05g Ginger Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3
10g Ginger Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3
15g Ginger Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3
Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a 5-hydroxytryptamine type-3 5-HT3 receptor antagonist ondansetron granisetron tropisetron and dolasetron mesylate and dexamethasone DM or the equivalent dose of IV methylprednisolone MePRDL on day 1 of courses 2 and 3
Symptoms are assessed on day -3 to day 1 of courses 2 and 3 and on days 1-4 of courses 1-3
Quality of life is assessed on day 4 of courses 1-3
Nausea and vomiting are assessed 4 times daily on days 1-4 of courses 1-3
PROJECTED ACCRUAL A total of 706 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| URCC-0114 | OTHER | NCI DCP | httpsreporternihgovquickSearchU10CA037420 |
| U10CA037420 | NIH | None | None |
| URCC U1902 | OTHER | None | None |