MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy (MEDEA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02135510|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: metoclopramide Drug: dexamethason Drug: palonosetron||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2013|
|Actual Primary Completion Date :||March 1, 2019|
|Actual Study Completion Date :||March 1, 2019|
|Active Comparator: metoclopramide||
|Active Comparator: dexamethason||
|Active Comparator: palonosetron||
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135510
|Den Helder, Noord Holland, Netherlands, 1782 GZ|
|Hilversum, Noord Holland, Netherlands, 1213 XZ|
|Medisch Centrum Alkmaar|
|Alkmaar, Noord-Holland, Netherlands, 1815 JD|
|Amstelveen, Noord-Holland, Netherlands, 1186 AM|
|Purmerend, Noord-Holland, Netherlands, 1441 RN|
|De Heel - Zaans Medisch Centrum|
|Zaandam, Noord-Holland, Netherlands, 1502 DV|