Chemotherapy-induced Nausea and Vomitting
Conditions
Interventions
experimental group:Olanzapine
control group:Dexmethasone
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patients 18 years of age or older with malignant disease who had not received previous chemotherapy;who need to use cisplatin-based dual-drug chemotherapy for the first time, ECOG score 0-2; (2) Expected survival time >= 3 months; (3) Neutrophil count >= 1.5 * 10^9 / L; (4) ALT and AST <= 3 times the normal upper limit; (5) Bilirubin <= 1.5 times the normal upper limit; (6) Serum creatinine <= 1.5 times the normal upper limit.
Exclusion criteria
Exclusion criteria: (1) History of CNS disease (e.g. brain metastases, seizure disorder). (2) Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone <= 30 days prior to registration or planned during protocol therapy. (3) Require concurrent radiation therapy of pharynx or abdomon. (4) Concurrent use of quinolone antibiotic therapy. (5) Chronic alcoholism. (6) Known hypersensitivity to olanzapine. (7) Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months. (8) History of uncontrolled diabetes mellitus. (9) Nausea or vomiting <= 24 hours prior to registration. (10) Use of antiemetic agent 48h before chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nausea-free Rate; | — |
Countries
China
Contacts
Public ContactZhigang Liu
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed