Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Olanzapine; Aprepitant; Palonosetron; Dexamethasone
Intervention description: 5mg,twice a day orally on day 1 to day 4; 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.; 0.25mg IV 30-60min before chemotherapy on day 1; 6mg IV on day 1 ，3.75mg IV on day 2 to 4
Intervention MeSH terms: Dexamethasone; Olanzapine; Aprepitant; Palonosetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chemotherapy nausea vomiting

Summary:

      The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in
      combination with olanzapine ,palonosetron and dexamethasone for the prevention of
      chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately
      emetogenic chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. Histologically or cytologically confirmed malignant disease

          3. Accept chemotherapy for the first time

          4. Patients who will receive high emetogenic cancer chemotherapy (HEC)
             (cisplatin>=70mg/m2,adriamycin in combination with cyclophosphamide
             ,cyclophosphamide>=1500mg/m2,adriamycin>60mg/m2,epirubicin>90mg/m2,dacarbazine，ifosfam
             ide>=2g/m2) or moderate emetogenic chemotherapy cancer
             (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)

          5. Written informed consent

        Exclusion Criteria:

          1. Pregnant or breast-feeding

          2. Uncontrolled psychosis history

          3. Inability or unwillingness to understand or cooperate with study procedures

          4. Central nervous system tumors primary or secondary

          5. Concurrent abdominal radiotherapy

          6. History of uncontrolled diabetes mellitus

          7. Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.

          8. Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial
             infarction with the previous six month

          9. Pre-existing nausea or vomiting

         10. Inadequate hematological function and abnormal liver and renal function.

         11. History of sensitivity to olanzapine

         12. Concurrent application of quinolone antibiotic therapy

         13. Treatment with another antipsychotic agent such as risperidone,quetiapine,
             clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the
             chemotherapy.

         14. Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole,
             pimozide)

         15. Concurrent application of systemic corticosteroids

         16. Active infection or gastrointestinal dysfunction