Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003213
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
Drugs to Reduce the Side Effects of Chemotherapy
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
A Randomized Double-Blind Trial to Compare the Clinical Efficacy and Safety of Granisetron vs Metoclopramide Combined to Dexamethasone in the Prophylaxis of Chemotherapy-Induced Delayed Emesis
Status:
COMPLETED
Status Verified Date:
2012-07
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 treated with chemotherapy It is not known whether receiving dexamethasone with granisetron is more effective than receiving dexamethasone with metoclopramide for reducing the side effects of chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy
Detailed Description:
OBJECTIVES I Compare the clinical efficacy and safety of Granisetron or Metoclopramide in combination with Dexamethasone in the prophylaxis of delayed nausea and vomiting induced by emetogenic cancer chemotherapy in patients with or without emesis in the acute phase
OUTLINE This is a randomized double blind study Patients are stratified by prior chemotherapy yes vs no regular alcohol consumption yes vs no and prior chemotherapy regimen cisplatincarboplatin vs others Patients receive dexamethasone and granisetron by mouth bid on day 0 Patients are then randomized to receive either granisetron or metoclopramide with dexamethasone concurrently with chemotherapy Arm I Patients receive granisetron by mouth bid on days 1-5 Dexamethasone and a placebo are administered by mouth once daily on days 1-5 Arm II Patients receive metoclopramide by mouth tid on days 1-5 Dexamethasone is administered by mouth once daily on days 1-5 Patients must complete a diary card daily for 6 days
PROJECTED ACCRUAL This study will accrue 360 patients
OUTLINE This is a randomized double blind study Patients are stratified by prior chemotherapy yes vs no regular alcohol consumption yes vs no and prior chemotherapy regimen cisplatincarboplatin vs others Patients receive dexamethasone and granisetron by mouth bid on day 0 Patients are then randomized to receive either granisetron or metoclopramide with dexamethasone concurrently with chemotherapy Arm I Patients receive granisetron by mouth bid on days 1-5 Dexamethasone and a placebo are administered by mouth once daily on days 1-5 Arm II Patients receive metoclopramide by mouth tid on days 1-5 Dexamethasone is administered by mouth once daily on days 1-5 Patients must complete a diary card daily for 6 days
PROJECTED ACCRUAL This study will accrue 360 patients
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 |
|---|---|---|---|
| CDR0000066073 | None | None | None |
| SWS-SAKK-9095 | None | None | None |
| EU-97035 | None | None | None |