Clinical trial · Interventional
MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethason | Drug | — | UNRESOLVED |
| metoclopramide | Drug | — | UNRESOLVED |
| palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- metoclopramide
- interventionNames
- Drug: metoclopramide
- type
- ACTIVE_COMPARATOR
- label
- dexamethason
- interventionNames
- Drug: dexamethason
- type
- ACTIVE_COMPARATOR
- label
- palonosetron
- interventionNames
- Drug: palonosetron
Primary outcomes (3)
- measure
- efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDvan 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. PMID 32735029