Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429702
Status:
TERMINATED
Last Update Posted:
2014-07-25
First Post:
2007-01-31
Brief Title:
Diphenhydramine Lorazepam and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Phase II Randomized Double-Blinded Study of an Antiemetic Pump Using Benadryl Avitan and Decadron BAD for Children Receiving Moderately or Highly Emetogenic Chemotherapy
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to poor accrual and lack of feasibility to finish study per DSMB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Diphenhydramine lorazepam and dexamethasone may help lessen or prevent nausea and vomiting in patients treated with chemotherapy It is not yet known whether diphenhydramine lorazepam and dexamethasone are more effective than standard therapy in treating nausea and vomiting caused by chemotherapy
PURPOSE This randomized phase II trial is studying diphenhydramine lorazepam and dexamethasone to see how well they work compared with standard therapy in treating nausea and vomiting caused by chemotherapy in young patients with newly diagnosed cancer
PURPOSE This randomized phase II trial is studying diphenhydramine lorazepam and dexamethasone to see how well they work compared with standard therapy in treating nausea and vomiting caused by chemotherapy in young patients with newly diagnosed cancer
Detailed Description:
OBJECTIVES
Primary
Compare the degree of chemotherapy-induced nausea and vomiting CINV in pediatric patients with newly diagnosed cancer treated with diphenhydramine hydrochloride lorazepam and dexamethasone vs standard antiemetic therapy during the first course of emetogenic chemotherapy
Secondary
Compare the degree of CINV during the first 3 days after completion of the first course of emetogenic chemotherapy in patients treated with these antiemetic regimens
OUTLINE This is a randomized prospective double-blind multicenter study Patients are stratified according to the emetogenic potential of their chemotherapy regimen high vs moderate Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy Patients also receive diphenhydramine hydrochloride lorazepam and dexamethasone by continuous infusion pump
Arm II Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy Patients also receive saline by continuous infusion pump
In both arms treatment continues during the first course of chemotherapy Patients may also receive rescue antiemetic medication to control breakthrough nausea or emesis
Patients and their parents complete the Adapted Rhodes Index of Nausea Vomiting and Retching- Measured by ChildParent questionnaire once before beginning chemotherapy twice daily during chemotherapy and for 3 days after completion of chemotherapy
PROJECTED ACCRUAL A total of 180 patients will be accrued for this study
Primary
Compare the degree of chemotherapy-induced nausea and vomiting CINV in pediatric patients with newly diagnosed cancer treated with diphenhydramine hydrochloride lorazepam and dexamethasone vs standard antiemetic therapy during the first course of emetogenic chemotherapy
Secondary
Compare the degree of CINV during the first 3 days after completion of the first course of emetogenic chemotherapy in patients treated with these antiemetic regimens
OUTLINE This is a randomized prospective double-blind multicenter study Patients are stratified according to the emetogenic potential of their chemotherapy regimen high vs moderate Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy Patients also receive diphenhydramine hydrochloride lorazepam and dexamethasone by continuous infusion pump
Arm II Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy Patients also receive saline by continuous infusion pump
In both arms treatment continues during the first course of chemotherapy Patients may also receive rescue antiemetic medication to control breakthrough nausea or emesis
Patients and their parents complete the Adapted Rhodes Index of Nausea Vomiting and Retching- Measured by ChildParent questionnaire once before beginning chemotherapy twice daily during chemotherapy and for 3 days after completion of chemotherapy
PROJECTED ACCRUAL A total of 180 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 |
|---|---|---|---|
| SCUSF-0503 | OTHER | None | None |
| U10CA081920 | NIH | H Lee Moffitt Cancer Center Research Base | httpsreporternihgovquickSearchU10CA081920 |
| HLMCC-0503 | OTHER | None | None |