Clinical trial NCT02135510: MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy
Official title: MEtoclopramide, DExamethasone or Axoli (Palonoseton) for the Prevention of Delayed Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy: the MEDEA-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Solid Tumors
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Noordwest Ziekenhuisgroep
name: Rijnstate
name: Tergooiziekenhuizen locatie Hilversum
name: Ziekenhuis Amstelland
First posted: 2014-05-12
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: efficacy
timeFrame: 24 to 160 hours
measure: tolerability
timeFrame: 24 to 160 hours
measure: cost-effectiveness
timeFrame: 24 to 160 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Den Helder
country: Netherlands
facility: Gemini Ziekenhuis
state: Noord Holland
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
state: Noord Holland
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
state: Noord-Holland
city: Amstelveen
country: Netherlands
facility: Ziekenhuis Amstelland
state: Noord-Holland
city: Purmerend
country: Netherlands
facility: Waterland Ziekenhuis
state: Noord-Holland
city: Zaandam
country: Netherlands
facility: De Heel - Zaans Medisch Centrum
state: Noord-Holland
city: Arnhem
country: Netherlands
facility: Rijnstate
Study officials:
References:
citation: van der Vorst MJDL, Toffoli EC, Beusink M, van Linde ME, van Voorthuizen T, Brouwer S, van Zweeden AA, Vrijaldenhoven S, Berends JC, Berkhof J, Verheul HMW. Metoclopramide, Dexamethasone, or Palonosetron for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy (MEDEA): A Randomized, Phase III, Noninferiority Trial. Oncologist. 2021 Jan;26(1):e173-e181. doi: 10.1634/theoncologist.2020-0305. Epub 2020 Aug 21.