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
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
-
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
-
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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