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

Solid Tumors Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135510
• Other study ID #: 2011/366
• Status: Completed
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2020
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors
• Vomiting

Intervention

Drug:
• metoclopramide

• dexamethason

• palonosetron

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Alkmaar	Alkmaar	Noord-Holland
Netherlands	Ziekenhuis Amstelland	Amstelveen	Noord-Holland
Netherlands	Rijnstate	Arnhem
Netherlands	Gemini Ziekenhuis	Den Helder	Noord Holland
Netherlands	Tergooiziekenhuizen	Hilversum	Noord Holland
Netherlands	Waterland Ziekenhuis	Purmerend	Noord-Holland
Netherlands	De Heel - Zaans Medisch Centrum	Zaandam	Noord-Holland

Sponsors (5)

Lead Sponsor	Collaborator
VU University Medical Center	Noordwest Ziekenhuisgroep, Rijnstate, Tergooiziekenhuizen locatie Hilversum, Ziekenhuis Amstelland

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 to 160 hours
Primary	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).	24 to 160 hours
Primary	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.	24 to 160 hours