Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting

Last updated: February 13, 2017
Sponsor: First Affiliated Hospital of Harbin Medical University
Overall Status: Completed

Phase

3

Condition

Colic

Lactose Intolerance

Vomiting

Treatment

N/A

Clinical Study ID

NCT02484911
GHYDZ-1225
  • Ages > 18
  • All Genders

Study 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

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,ifosfamide>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)

  5. Written informed consent

Exclusion

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 myocardialinfarction 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 thechemotherapy.

  14. Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole,pimozide)

  15. Concurrent application of systemic corticosteroids

  16. Active infection or gastrointestinal dysfunction

Study Design

Total Participants: 120
Study Start date:
May 01, 2015
Estimated Completion Date:
January 31, 2017

Study Description

Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,palonosetron and dexamethasone .During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.

Connect with a study center

  • First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150000
    China

    Site Not Available

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