malignant neoplasm
Conditions
Interventions
Experimental:Olanzapine + Palonosetron + Dexamethsone
Control:Palonositron
Sponsors
the Fourth Affiliated Hospital of China Medical University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with lung cancer or gastric cancer et al; with defined pathological diagnosis; will accept initial treatment or retreatment with 3-day cisplatin based chemotherapy; 2. Age over 18 years old, and predicted life expectancy longer than 3 months; 3. ECOG less than 2; 4. With sufficient bone marrow reserve function: white cell count more than 4000/ul, neutrophile granulocyte count more than 2000/ul, HB more than 10 g/L, platelet count more than 80,000/ul in blood routine; 5. With normal renal and hepatic function; 6. With normal cardiac function that could tolerate the chemotherapy (without previous arrhythmia, uncontrollable congestive heart failure and acute myocardial infarction in recent 6 months); 7. Without nausea and vomiting 24 hours before the chemotherapy; 8. Without cognitive disorder; 9. Without previous diseases in central nervous system, such as uncontrollable brain metastases, epilepsia; 10. Without mental disorder (also do not belong to the following conditions: patients who have been used clozapine, risperidone, quetiapine, phenothiazine or butyrophen for 30 days, or need continue to use them during the study. Patients who have been used phenothiazine for long time, but it is acceptable if the phenothiazine is used as rescue); 11. Non abdominal concurrent chemoradiotherapy; 12. Without uncontrollable diabetes mellitus; 13. With good compliance: all of the patients could sign the informed consent and agree to participate in the clinical study.
Exclusion criteria
Exclusion criteria: 1. chemotherapy with Olanzapine/palonosetron in antiemetic scheme; 2. Female in lactation or pregnancy; 3. Patients who will accepted radiotherapy during the trial; 4. With digestive tract obstruction or narrow angle glaucoma; 5. With serious cardiac, hepatic or renal disease and metabolic dysfunction; 6.With intake of mental or sedative medicine; 7. With brain metastases(high intracranial pressure symptom) or epilepsia attack history; 8. With intake of antiemetic medicine within 24 hours or has vomited before chemotherapy; 9. With chronic alcoholism or drug psychological dependence; 10. With allergic reaction to Olanzapine or 5-HT3 antagonist; 11. With chemotherapy contraindication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response(CR) of ovreall phase;safety and effectiveness of Olanzapine; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and effectiveness of Palonosetron; | — |
Countries
China
Contacts
Public ContactShiyong Wang
Outcome results
None listed