Olanzapine versus Aprepitant in the triplet regimen for preventing highly emetogenic chemotherapy-induced nausea and vomiting: a double blind, non-inferiority, randomized phase 3 trial

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2018
INTERVENTION: The group(OLZ group) which received olanzapine from day1 to day4 in addition to granisetron and dexamethasone. The group(APR group) which received aprepitant from day1 to day3 in addition to granisetron and dexamethasone. CONDITION: malignant tumor(only solid tumor) PRIMARY OUTCOME: overall complete response (no emetic episodes and no use of rescue medication) rate SECONDARY OUTCOME: acute complete response rate(CR), delayed CR, vomiting rate, nausea rate, safety, adverse event and quality of life INCLUSION CRITERIA: 1)Patients 18 years of age or older with malignant disease who had not received previous chemotherapy 2)Patients who were scheduled to receive highly emetogenic chemotherapy 3)ECOG performance status of 0, 1, or 2. 4) a serum creatinine level of 2.0 mg per deciliter or less, an AST or ALT level that was no more than 3 times the upper limit of the normal range, and an absolute neutrophil count of at least 1500 per cubic millimeter
Epistemonikos ID: 84711224fbbf196e8af6f27324c246e5cc6d7ef6
First added on: Aug 24, 2024