Trial | NCT02135510  Report issue

Title

MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy
MEtoclopramide, DExamethasone or Axoli (Palonoseton) for the Prevention of Delayed Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy: the MEDEA-trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    249
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).
Study Started
Jun 30
2013
Primary Completion
Mar 01
2019
Study Completion
Mar 01
2019
Last Update
Mar 31
2020

Drug metoclopramide

Drug dexamethason

Drug palonosetron

dexamethason Active Comparator

palonosetron Active Comparator

metoclopramide Active Comparator

Criteria 

Inclusion Criteria:

Patient has been diagnosed with histologically or cytologically confirmed solid cancer
Starting with first cycle of chemotherapy of moderate emetogenic risk, which does not include a combination of anthracycline plus cyclophosphamide
Age ≥ 18
WHO ≤ 1
Patient is able to understand and speak Dutch

Exclusion Criteria:

Patient with nausea and/or vomiting in 48 hours before start of chemotherapy treatment
Patient submitted to concomitant radiotherapy or submitted to radiotherapy 15 days before start of chemotherapy or planned to receive radiotherapy during 8 days after administration of chemotherapy
Patient with concomitant severe comorbidy, such as: o Intestinal obstruction o Active peptic ulcer o Hypercalcemia o Uncontrolled diabetes mellitus o Pheochromocytoma o Tardive dyskinesia o Epilepsia o Active infective diseases o Brain - or leptomeningeal metastases o Psychiatrical disorders o Parkinsonism
Current use of corticosteroids (similar to prednisone ≥ 10 milligrams per day)
Current alcohol abuse
Pregnancy
No Results Posted