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metoclopramide

dexamethason

palonosetron

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).

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

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.

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy	NCT02135510	Solid Tumors	metoclopramide dexamethason palonosetron	18 Years -	Amsterdam UMC, location VUmc
MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy	NCT02135510	Solid Tumors	metoclopramide dexamethason palonosetron	18 Years -	Amsterdam UMC, location VUmc

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