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

NCT02484911 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-03-30

Study results available
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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.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Olanzapine

5mg,twice a day orally on day 1 to day 4

DRUG

Aprepitant

125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.

DRUG

Palonosetron

0.25mg IV 30-60min before chemotherapy on day 1

DRUG

Dexamethasone

6mg IV on day 1 ,3.75mg IV on day 2 to 4

Sponsors & Collaborators

  • Harbin Medical University

    collaborator OTHER
  • First Affiliated Hospital of Harbin Medical University

    lead OTHER

Principal Investigators

  • Daxin Zhang, MD · First Affiliated Hospital of Harbin Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-09-30
Completion
2017-01-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02484911 on ClinicalTrials.gov