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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2019-03-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metoclopramide

Group Type ACTIVE_COMPARATOR

metoclopramide

Intervention Type DRUG

dexamethason

Group Type ACTIVE_COMPARATOR

dexamethason

Intervention Type DRUG

palonosetron

Group Type ACTIVE_COMPARATOR

palonosetron

Intervention Type DRUG

Interventions

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metoclopramide

Intervention Type DRUG

dexamethason

Intervention Type DRUG

palonosetron

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No