MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy (MEDEA)

March 30, 2020 updated by: H.M.W. Verheul, Amsterdam UMC, location VUmc

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Arnhem, Netherlands
        • Rijnstate
    • Noord Holland
      • Den Helder, Noord Holland, Netherlands, 1782 GZ
        • Gemini Ziekenhuis
      • Hilversum, Noord Holland, Netherlands, 1213 XZ
        • Tergooiziekenhuizen
    • Noord-Holland
      • Alkmaar, Noord-Holland, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar
      • Amstelveen, Noord-Holland, Netherlands, 1186 AM
        • Ziekenhuis Amstelland
      • Purmerend, Noord-Holland, Netherlands, 1441 RN
        • Waterland Ziekenhuis
      • Zaandam, Noord-Holland, Netherlands, 1502 DV
        • De Heel - Zaans Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: metoclopramide
Drug: metoclopramide
Active Comparator: dexamethason
Drug: dexamethason
Active Comparator: palonosetron
Drug: palonosetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy
Time Frame: 24 to 160 hours
Primary efficacy endpoint: the proportion of patients reporting complete response during the overall 24 to 160 hours after initiation of the first cycle of moderately emetogenic chemotherapeutic (MEC). Complete response is defined as no vomiting and nausea and no use of rescue medication. A diary will be used to document the date and time of any emetic episodes and use of rescue medication, as well as daily nausea ratings.
24 to 160 hours
tolerability
Time Frame: 24 to 160 hours
Primary tolerability endpoint: the proportion of patients with minimal or no antiemetic therapy-related side effects according to the Dexamethasone Symptom Questionnaire (DSQ) questionnaire, the Abnormal Involuntary Movement Scale (AIMS) and Aprepitant questionnaire during the first cycle of moderately emetogenic chemotherapeutic (MEC).
24 to 160 hours
cost-effectiveness
Time Frame: 24 to 160 hours
Primary cost-effectiveness endpoint: total antiemetic medication costs per treatment regimen during the first cycle of Moderately Emetogenic Chemotherapy (MEC). A diary will be used to document the use of antiemetics and rescue medication. Total medication costs will be calculated from this.
24 to 160 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

Noordwest Ziekenhuisgroep
Ziekenhuis Amstelland
Rijnstate
Tergooiziekenhuizen locatie Hilversum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/366

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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