MEtoclopramide, DExamethasone or Aloxi (palonosetron) for the prevention of delayed chemotherapy-induced nausea and vomiting in moderately emetogenic non-AC-based chemotherapy: the MEDEA trial

Phase 3

Completed

Conditions: alle vormen van solide tumoren
chemotherapy induced nausea and vomiting
nausea and vomiting caused by chemotherapy

Registration Number: NL-OMON44716

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 450

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary efficacy endpoint: the proportion of patients reporting complete<br /><br>response during the overall 24 to 160 hours after initiation of the first cycle<br /><br>of MEC. Complete response is defined as no vomiting and nausea and no use of<br /><br>rescue medication. A diary will be used to document the date and time of any<br /><br>emetic episodes and use of rescue medication, as well as daily nausea ratings.<br /><br><br /><br>Primary tolerability endpoint: the proportion of patients with minimal or no<br /><br>antiemetic therapy-related side effects according to the DSQ questionnaire, the<br /><br>AIMS and Aloxi questionnaire during the first cycle of MEC.<br /><br><br /><br>Primary cost-effectiveness endpoint: total antiemetic medication costs per<br /><br>treatment regimen during the first cycle of MEC. A diary will be used to<br /><br>document the use of antiemetics and rescue medication. Total medication costs<br /><br>will be calculated from this. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy endpoint: the proportion of patients with minimal or no<br /><br>impact on daily life of CINV according to the FLIE questionnaire during the<br /><br>first cycle of MEC.<br /><br><br /><br>Secondary tolerability endpoint: the proportion of patients with minimal or no<br /><br>impact on daily life of antiemetic therapy-related side effects according to<br /><br>the EORTC QLQ C-30 during the first cycle of chemotherapy.</p><br>