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

Primary Purpose

Solid Tumors

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
metoclopramide
dexamethason
palonosetron
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gemini Ziekenhuis
  • Tergooiziekenhuizen
  • Medisch Centrum Alkmaar
  • Ziekenhuis Amstelland
  • Waterland Ziekenhuis
  • De Heel - Zaans Medisch Centrum
  • Rijnstate

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

metoclopramide

dexamethason

palonosetron

Arm Description

Outcomes

Primary Outcome Measures

efficacy
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.
tolerability
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).
cost-effectiveness
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.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2014
Last Updated
March 30, 2020
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Noordwest Ziekenhuisgroep, Rijnstate, Tergooiziekenhuizen locatie Hilversum, Ziekenhuis Amstelland
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1. Study Identification

Unique Protocol Identification Number
NCT02135510
Brief Title
MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy
Acronym
MEDEA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Noordwest Ziekenhuisgroep, Rijnstate, Tergooiziekenhuizen locatie Hilversum, Ziekenhuis Amstelland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metoclopramide
Arm Type
Active Comparator
Arm Title
dexamethason
Arm Type
Active Comparator
Arm Title
palonosetron
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
metoclopramide
Intervention Type
Drug
Intervention Name(s)
dexamethason
Intervention Type
Drug
Intervention Name(s)
palonosetron
Primary Outcome Measure Information:
Title
efficacy
Description
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.
Time Frame
24 to 160 hours
Title
tolerability
Description
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).
Time Frame
24 to 160 hours
Title
cost-effectiveness
Description
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.
Time Frame
24 to 160 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Gemini Ziekenhuis
City
Den Helder
State/Province
Noord Holland
ZIP/Postal Code
1782 GZ
Country
Netherlands
Facility Name
Tergooiziekenhuizen
City
Hilversum
State/Province
Noord Holland
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
State/Province
Noord-Holland
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Ziekenhuis Amstelland
City
Amstelveen
State/Province
Noord-Holland
ZIP/Postal Code
1186 AM
Country
Netherlands
Facility Name
Waterland Ziekenhuis
City
Purmerend
State/Province
Noord-Holland
ZIP/Postal Code
1441 RN
Country
Netherlands
Facility Name
De Heel - Zaans Medisch Centrum
City
Zaandam
State/Province
Noord-Holland
ZIP/Postal Code
1502 DV
Country
Netherlands
Facility Name
Rijnstate
City
Arnhem
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32735029
Citation
van der Vorst MJDL, Toffoli EC, Beusink M, van Linde ME, van Voorthuizen T, Brouwer S, van Zweeden AA, Vrijaldenhoven S, Berends JC, Berkhof J, Verheul HMW. Metoclopramide, Dexamethasone, or Palonosetron for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy (MEDEA): A Randomized, Phase III, Noninferiority Trial. Oncologist. 2021 Jan;26(1):e173-e181. doi: 10.1634/theoncologist.2020-0305. Epub 2020 Aug 21.
Results Reference
derived

Learn more about this trial

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

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