Malignant tumor
Conditions
Interventions
2.5mg, 5mg, 7.5mg, 10mg, 15mg:2.5mg, 5mg, 7.5mg, 10mg, 15mg
Sponsors
The General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old, men and women; 2. Pathology confirmed as malignant solid tumors; 3. The ECOG PS: 0 to 2 points; 4. Accept the high risk to vomit chemotherapy: Cisplatin: 70 mg/m2 or; Epirubicin :more than 90 mg/m2 or doxorubicin 60 mg/m2 combined cyclophosphamide 600-1000 mg/m2; 5. The main organ function is normal, meet the following requirements: (1) the blood routine examination, must be in accordance with no blood transfusion (in 14 days) HB 90 g/L or higher; the ANC acuity 1.5 x 10^9/L; PLT acuity 80 x 10^9/L; (2) and biochemical examination must be in accordance with the following criteria: BIL 2.0 mg/dL or less; ALT and AST < 120 u/L or less; serum Cr 177 mu mol/L or less, creatinine clearance or 50 ml/min (Cockcroft - Gault formula); 6. Without nausea and vomiting before the treatment of 24 hours; 7. Using olanzapine combined scheme by the attending doctor anti-nausea treatment; 8. Patients are willing to join in this study, and signed informed consent (ICF); 9. Women of childbearing age should be carried out in the group of 7 days before pregnancy test results were negative serum or urine, and childbearing age patients (male/female) voluntarily appropriate precautions in the experimental process.
Exclusion criteria
Exclusion criteria: 1. patients of childbearing potential (male and female had to consent to use adequate contraception throughout the protocol therapy; females of childbearing potential had to have a negative urine pregnancy test; no severe cognitive compromise; no known history of central nervous system disease (e.g., brain metastases, seizure disorder); no treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days; 2. prior to or during the protocol therapy; chronic phenothiazine administration as an antipsychotic agent was not allowed, but patients may receive prochlorperazine and other phenothiazines as rescue antiemetic therapy; no concurrent use of amifostine (Ethyol); no concurrent abdominal radiotherapy; no concurrent use of quinolone antibiotic therapy; no chronic alcoholism (as determined by the investigator); no known hypersensitivity to olanzapine; no known cardiac arrhythmia,uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months; and no history of uncontrolled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sleepiness;dizziness;constipation;dry;weakness;expectation; | — |
Secondary
| Measure | Time frame |
|---|---|
| the effective rate of release nause and vomitting; | — |
Countries
China
Contacts
Public ContactXiaomei Li
PLA 301th Hospital
Outcome results
None listed