non-small cell lung cancer
Conditions
Interventions
control: palonosetron, and dexamethasone
Experimental group:dexamethasone,aprepitant and palonosetron
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Treatment naive NSCLC patients who can complete 4-6 cycles of moderate emetic regimen chemotherapy. Patients selected for this study must meet all the following criteria: 1. aged > 18 years; 2. delayed vomiting after chemotherapy and subsequent chemotherapy; 3. Karnofsky score (> 60); 4. life expectancy (> 3 months); 5. The main organ functions are normal, that is to say, the following criteria should be met: (1) blood routine examination criteria: HB > 90 g/L (no blood transfusion within 14 days); ANC > 1.5 *10^9/L; PLT > 75 *10^9/L; (2) biochemical examination should meet the following criteria: TBIL < 1.5 ULN (upper limit of normal value); ALT and AST < 3.0 ULN; if there is liver metastasis, ALT and AST < 3.0 ULN. AST was less than 5 ULN, serum Cr was less than 1 ULN, and endogenous creatinine clearance rate was more than 60 ml/min (Cockcroft-Gault formula). Patients can read, understand and complete research questionnaires and logs, including the Nausea and Vomiting Questionnaire (FLIE) and dietary diary questions.
Exclusion criteria
Exclusion criteria: 1. patients have received research drugs outside the scope of the study in the past four weeks or during the study period, and the toxicity of the recent treatment has not been eliminated; 2. Pregnancy, breast-feeding women, women of childbearing age who want to be pregnant or who only use oral contraceptives; 3. Patients suffer from important organ disorders or diseases, such as history of myocardial infarction, severe epilepsy requiring medication, etc.; 4. Patients with mental disabilities or severe emotional or mental disorders; 5. With a history of other malignant tumors within 5 years (excluding cured cervical or skin basal cell carcinomas); 6. Patients with uncontrolled diseases, such as active infections (such as pneumonia) or diabetic ketoacidosis or gastrointestinal obstruction, may be biased by the results of the study or exposed to unnecessary risks in patients receiving the drug; 7. Patients are receiving any dose of systemic glucocorticoid therapy; however, local and inhaled glucocorticoids are allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate of acute CINV;complete response rate of delay CINV; | — |
Countries
China
Contacts
Public ContactZhang Lemeng
Hunan Cancer Hospital
Outcome results
None listed