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

Amsterdam UMC, location VUmc249 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

249

Conditions

Solid Tumors

Interventions

metoclopramideDRUG

dexamethasonDRUG

palonosetronDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Medisch Centrum Alkmaar

Alkmaar, North Holland, Netherlands

Ziekenhuis Amstelland

Amstelveen, North Holland, Netherlands

Gemini Ziekenhuis

Den Helder, North Holland, Netherlands

Tergooiziekenhuizen

Hilversum, North Holland, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 24 to 160 hours

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).

Time frame: 24 to 160 hours

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.

Time frame: 24 to 160 hours

Data from ClinicalTrials.gov

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