Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475085
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2007-05-16
Brief Title:
Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Sponsor:
Joseph Roscoe
Organization:
University of Rochester
Study Overview
Official Title:
Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
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 Antiemetic drugs such as granisetron dexamethasone prochlorperazine aprepitant and palonosetron may help lessen or prevent nausea It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy
PURPOSE This randomized phase III trial is comparing different combinations of granisetron dexamethasone prochlorperazine aprepitant and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer
PURPOSE This randomized phase III trial is comparing different combinations of granisetron dexamethasone prochlorperazine aprepitant and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer Arms I and IV
Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients Arms I and II
Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients Arms III and IV
Secondary
Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients Arms I and IV
Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients Arms I and II
Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients Arms III and IV
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to CCOP center and gender Patients are randomized to 1 of 4 treatment arms Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment
Arm I Patients receive palonosetron hydrochloride IV dexamethasone IV and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3
Arm II Patients receive granisetron hydrochloride IV dexamethasone IV and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3
Arm III Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1 oral aprepitant once daily on days 1-3 and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3
Arm IV Patients receive palonosetron hydrochloride IV dexamethasone IV and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3
Quality of life is assessed at baseline and on day 4 Nausea and vomiting fatigue sleep quality exercise and the need for rescue medication metoclopramide are assessed on days 1-4
PROJECTED ACCRUAL A total of 890 patients will be accrued for this study
Primary
Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer Arms I and IV
Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients Arms I and II
Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients Arms III and IV
Secondary
Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients Arms I and IV
Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients Arms I and II
Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients Arms III and IV
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to CCOP center and gender Patients are randomized to 1 of 4 treatment arms Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment
Arm I Patients receive palonosetron hydrochloride IV dexamethasone IV and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3
Arm II Patients receive granisetron hydrochloride IV dexamethasone IV and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3
Arm III Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1 oral aprepitant once daily on days 1-3 and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3
Arm IV Patients receive palonosetron hydrochloride IV dexamethasone IV and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3
Quality of life is assessed at baseline and on day 4 Nausea and vomiting fatigue sleep quality exercise and the need for rescue medication metoclopramide are assessed on days 1-4
PROJECTED ACCRUAL A total of 890 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 |
|---|---|---|---|
| URCC-U1105 | OTHER | University of Rochester | httpsreporternihgovquickSearchU10CA037420 |
| U10CA037420 | NIH | None | None |