In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.
In order to decrease this delayed CINV, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy. The investigators hypothesize that this antiemetic schedule will significantly reduce the delayed CINV compared to historical controls
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
85
Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
Northside Hospital
Atlanta, Georgia, United States
Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting
Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.
Time frame: 120 hours
Complete Remission During Acute Phase Post-chemotherapy
Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)
Time frame: 24 hours
Complete Remission During Overall Chemotherapy Time Period
Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period
Time frame: 120 hours
Complete Control Rate for Nausea & Vomiting
Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)
Time frame: 120 hours
Emetic Episodes
Number of emetic episodes
Time frame: 120 Hours
Patients Who Experience First Emetic Episode Within 24 Hours
Number of patients with first emetic episode experienced within 24 hours
Time frame: 24 hours
Number of Patients That Required First Administration of Rescue Medication Within 24 Hours
Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours
Time frame: 24 hours
Number of Patients That Experience Treatment Failure Within the First 24 Hours
Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours
Time frame: 24 hours
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