Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-25 @ 4:33 PM
Study NCT ID:
NCT00020657
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
Sponsor:
Gary Morrow
Organization:
Study Overview
Official Title:
Treatment of Delayed Nausea: What Works Best?
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 may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy.
PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
Detailed Description:
OBJECTIVES:
* Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer.
* Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients.
* Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine.
* Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.
Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1.
Patients are then randomized to 1 of 3 antiemetic arms.
* Arm I: Patients receive oral prochlorperazine every 8 hours on days 2 and 3.
* Arm II: Patients receive oral ondansetron every 12 hours, oral granisetron every 12 hours, or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3.
* Arm III: Patients receive oral prochlorperazine as needed, up to 4 times per day, on days 2 and 3.
Quality of life is assessed at baseline and on day 4.
PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study within 3 years.
* Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer.
* Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients.
* Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine.
* Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.
Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1.
Patients are then randomized to 1 of 3 antiemetic arms.
* Arm I: Patients receive oral prochlorperazine every 8 hours on days 2 and 3.
* Arm II: Patients receive oral ondansetron every 12 hours, oral granisetron every 12 hours, or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3.
* Arm III: Patients receive oral prochlorperazine as needed, up to 4 times per day, on days 2 and 3.
Quality of life is assessed at baseline and on day 4.
PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study within 3 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: