The Results of the Comparison between Olanzapine and One-Dose Dexamethasone and Four-Day Dexamethasone in Prevention of Chemotherapy induced Nausea and Vomiting in Patients with Pancreatic Cancer Receiving Modified FOLFIRINOX

Authors
Category Primary study
Registry of TrialsTCTR
Year 2023
INTERVENTION: antiemetic regimen with olanzapine 5 mg before chemotherapy and on day 2‐4 before bedtime without dexamethasone on day 2‐4. All patients received ondansetron 8 mg and dexamethasone 4 mg intravenously as the premedication approximately 30 minutes before chemotherapy on day 1, and ondansetron (8mg) orally on day 2‐4.,antiemetic regimen with placebo before chemotherapy, dexamethasone orally on day 2‐4 before bedtime. All patients received ondansetron 8 mg and dexamethasone 4 mg intravenously as the premedication approximately 30 minutes before chemotherapy on day 1, and ondansetron (8mg) orally on day 2‐4. Experimental Drug,Placebo Comparator Drug Olanzapine arm,Dexamethasone arm CONDITION: modified FOLFIRINOX; pancreatic cancer; dexamethasone; chemotherapy‐induced nausea and vomiting; Olanzapine Patients with pancreatic cancer plan to receive modified FOLFIRINO Xchemotherapy regimen ; modified FOLFIRINOX; pancreatic cancer; dexamethasone; chemotherapy‐induced nausea and vomiting; Olanzapine PRIMARY OUTCOME: complete response (CR) of vomiting (no vomiting) in the overall phase (0‐120 hours) after start chemotherapy 0‐120 hours after start chemotherapy rate of vomiting (no vomiting) in the overall phase SECONDARY OUTCOME: CR of nausea (no nausea) in the overall phase 0‐120 hours after start chemotherapy rate of nausea (no nausea) ,incidence of hyperglycemia during 2 chemotherapy sessions incidence of hyperglycemia INCLUSION CRITERIA: Eligible patients were 18 and 80 years old patients with Eastern Cooperative Oncology group (ECOG) performance status 0‐1
Epistemonikos ID: f6cb997e0c235fcb79df5dbac57e16987d527a46
First added on: Feb 20, 2024