MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy
NCT02135510 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249
Last updated 2020-03-31
Summary
In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC).
Conditions
Interventions
- DRUG
-
metoclopramide
- DRUG
-
dexamethason
- DRUG
-
palonosetron
Sponsors & Collaborators
-
Noordwest Ziekenhuisgroep
collaborator OTHER -
Rijnstate
collaborator UNKNOWN -
Tergooiziekenhuizen locatie Hilversum
collaborator UNKNOWN -
Ziekenhuis Amstelland
collaborator OTHER -
Amsterdam UMC, location VUmc
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2019-03-01
- Completion
- 2019-03-01
Countries
- Netherlands
Study Locations
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