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

Amsterdam UMC, location VUmc

Status and phase

Completed

Phase 3

Conditions

Solid Tumors

Treatments

Drug: metoclopramide

Drug: dexamethason

Drug: palonosetron

Study type

Interventional

Funder types

Other

Identifiers

NCT02135510

2011/366

Details and patient eligibility

About

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).

Enrollment

249 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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