Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV
Chemotherapy-induced Nausea and Vomiting
About this trial
This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older with malignant disease; Life expectancy ≥ 3 months; Scheduled to receive highly emetogenic chemotherapy; Had a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Exclusion Criteria: There are contraindications to chemotherapy(Absolute number of neutrophils ≤ 1,500/uL, hemoglobin ≤ 90g/L, platelet count ≤ 10000/uL, serum creatinine level ≥ 2.0mg/dl (177 μmol/L), ALT and AST ≥ 2.5 times the upper normal limit, bilirubin ≥ 1.5 times the upper normal limit); History of central nervous system disease (e.g., brain metastases or a seizure disorder); Severe cognitive impairment; Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; Concurrent use of pharyngeal or abdominal radiotherapy; Concurrent use of quinolone antibiotics; Concurrent use of Amifostine; Chronic alcoholism; Known hypersensitivity to olanzapine; Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months; Known uncontrolled diabetes mellitus; Vomiting or retching 24 hours before chemotherapy; Use of anti-emesis drugs 48 hours before chemotherapy; Patients who require medication with dexamethasone for pretreatment.
Sites / Locations
- West China Hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
5HT3RA+Olanzapine
5HT3RA+Olanzapine+Dexamethasone
Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.
Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.