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

NCT02135510 | Completed Phase 3 DMC

• 1 other identifier: 2011/366
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 7

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).

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (3)

• efficacy

  Primary efficacy endpoint: the proportion of patients reporting complete response during the overall 24 to 160 hours after initiation of the first cycle of moderately emetogenic chemotherapeutic (MEC). Complete response is defined as no vomiting and nausea and no use of rescue medication. A diary will be used to document the date and time of any emetic episodes and use of rescue medication, as well as daily nausea ratings.

  24 to 160 hours

• tolerability

  Primary tolerability endpoint: the proportion of patients with minimal or no antiemetic therapy-related side effects according to the Dexamethasone Symptom Questionnaire (DSQ) questionnaire, the Abnormal Involuntary Movement Scale (AIMS) and Aprepitant questionnaire during the first cycle of moderately emetogenic chemotherapeutic (MEC).

  24 to 160 hours

• cost-effectiveness

  Primary cost-effectiveness endpoint: total antiemetic medication costs per treatment regimen during the first cycle of Moderately Emetogenic Chemotherapy (MEC). A diary will be used to document the use of antiemetics and rescue medication. Total medication costs will be calculated from this.

  24 to 160 hours

Study Arms (3)

metoclopramide

ACTIVE COMPARATOR

Drug: metoclopramide

dexamethason

ACTIVE COMPARATOR

Drug: dexamethason

palonosetron

ACTIVE COMPARATOR

Drug: palonosetron

Interventions

metoclopramide DRUG

metoclopramide

dexamethason DRUG

dexamethason

palonosetron DRUG

palonosetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Noordwest Ziekenhuisgroep: collaborator
• Rijnstate: collaborator
• Tergooiziekenhuizen locatie Hilversum: collaborator
• Ziekenhuis Amstelland: collaborator

Study Sites (7)

Medisch Centrum Alkmaar

Alkmaar, North Holland, 1815 JD, Netherlands

Location

Ziekenhuis Amstelland

Amstelveen, North Holland, 1186 AM, Netherlands

Location

Gemini Ziekenhuis

Den Helder, North Holland, 1782 GZ, Netherlands

Location

Tergooiziekenhuizen

Hilversum, North Holland, 1213 XZ, Netherlands

Location

Waterland Ziekenhuis

Purmerend, North Holland, 1441 RN, Netherlands

Location

De Heel - Zaans Medisch Centrum

Zaandam, North Holland, 1502 DV, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 32735029 DERIVED

MeSH Terms

Interventions

Metoclopramide; Palonosetron

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Department Medical Oncology

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 12, 2014
• Study Start: June 1, 2013
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

NL (7)