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

Last updated: March 30, 2020
Sponsor: VU University Medical Center
Overall Status: Completed

Phase

3

Condition

Vomiting

Solid Tumors

Treatment

N/A

Clinical Study ID

NCT02135510
2011/366
  • Ages > 18
  • All Genders

Study 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

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 notinclude a combination of anthracycline plus cyclophosphamide

  • Age ≥ 18

  • WHO ≤ 1

  • Patient is able to understand and speak Dutch

Exclusion

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 daysbefore start of chemotherapy or planned to receive radiotherapy during 8 days afteradministration of chemotherapy

  • Patient with concomitant severe comorbidy, such as: o Intestinal obstruction o Activepeptic ulcer o Hypercalcemia o Uncontrolled diabetes mellitus o Pheochromocytoma oTardive dyskinesia o Epilepsia o Active infective diseases o Brain - or leptomeningealmetastases o Psychiatrical disorders o Parkinsonism

  • Current use of corticosteroids (similar to prednisone ≥ 10 milligrams per day)

  • Current alcohol abuse

  • Pregnancy

Study Design

Total Participants: 249
Study Start date:
June 01, 2013
Estimated Completion Date:
March 01, 2019

Connect with a study center

  • Gemini Ziekenhuis

    Den Helder, Noord Holland 1782 GZ
    Netherlands

    Site Not Available

  • Tergooiziekenhuizen

    Hilversum, Noord Holland 1213 XZ
    Netherlands

    Site Not Available

  • Medisch Centrum Alkmaar

    Alkmaar, Noord-Holland 1815 JD
    Netherlands

    Site Not Available

  • Ziekenhuis Amstelland

    Amstelveen, Noord-Holland 1186 AM
    Netherlands

    Site Not Available

  • Waterland Ziekenhuis

    Purmerend, Noord-Holland 1441 RN
    Netherlands

    Site Not Available

  • De Heel - Zaans Medisch Centrum

    Zaandam, Noord-Holland 1502 DV
    Netherlands

    Site Not Available

  • Rijnstate

    Arnhem,
    Netherlands

    Site Not Available

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