Metoclopramide, dexamethasone or Aloxi for the prevention of delayed chemotherapy-induced nausea and vomiting in moderately emetogenic non-AC-based chemotherapy: the MEDEA trial - MEDEA

VU University Medical Center Amsterdam0 个研究点目标入组 450 人开始时间: 2011年12月13日最近更新: 2020年3月18日

试验速览

暂无简介。

•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 (attachment 1)
•Patient is able to understand and speak Dutch
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•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:
•oIntestinal obstruction
•oActive peptic ulcer
•oHypercalcemia
•oUncontrolled diabetes mellitus
•oPheochromocytoma
•oTardive dyskinesia
•oActive infective diseases
•oBrain – or leptomeningeal metastases
•oPsychiatrical disorders
•oParkinsonism
•Current use of corticosteroids (similar to prednisone = 10 milligrams per day)
•Current alcohol abuse
•Pregnancy

发起方

VU University Medical Center Amsterdam