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

Phase 3

Completed

• Conditions: Solid Tumors
• Interventions: Drug: dexamethason; Drug: metoclopramide; Drug: palonosetron

• Registration Number: NCT02135510
• Lead Sponsor: Amsterdam UMC, location VUmc

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-12
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamethason	dexamethason	-
metoclopramide	metoclopramide	-
palonosetron	palonosetron	-

Primary Outcome Measures

Name	Time	Method
cost-effectiveness	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.
efficacy	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	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).

Trial Locations

Locations (7)

Tergooiziekenhuizen; 🇳🇱 Hilversum, Noord Holland, Netherlands

Rijnstate; 🇳🇱 Arnhem, Netherlands

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Noord-Holland, Netherlands

Ziekenhuis Amstelland; 🇳🇱 Amstelveen, Noord-Holland, Netherlands

Waterland Ziekenhuis; 🇳🇱 Purmerend, Noord-Holland, Netherlands

Gemini Ziekenhuis; 🇳🇱 Den Helder, Noord Holland, Netherlands

De Heel - Zaans Medisch Centrum; 🇳🇱 Zaandam, Noord-Holland, Netherlands