Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

Last updated: October 11, 2016
Sponsor: Wuhan Union Hospital, China
Overall Status: Trial Status Unknown

Phase

3

Condition

Effects Of Chemotherapy

Vomiting

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT02933099
WuhanUHC
  • Ages > 18
  • All Genders

Study Summary

To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years of age or older

  2. Histologically or cytologically confirmed nasopharyngeal carcinoma

  3. Accept chemotherapy for the first time

  4. Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV),cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV)

  5. Written informed consent

Exclusion

Exclusion Criteria:

  1. regnant 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: 300
Study Start date:
October 01, 2016
Estimated Completion Date:
December 31, 2018

Study Description

Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant, palonosetron and dexamethasone .In the other group,patients will accept the same dose of 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.