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

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ClinicalTrials.gov Identifier: NCT02135510
Recruitment Status : Recruiting
First Posted : May 12, 2014
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Noordwest Ziekenhuisgroep
Rijnstate
Tergooiziekenhuizen locatie Hilversum
Ziekenhuis Amstelland
Information provided by (Responsible Party):
H.M.W. Verheul, VU University Medical Center

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).

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: metoclopramide Drug: dexamethason Drug: palonosetron Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2013
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: metoclopramide Drug: metoclopramide
Active Comparator: dexamethason Drug: dexamethason
Active Comparator: palonosetron Drug: palonosetron



Primary Outcome Measures :
  1. efficacy [ Time Frame: 24 to 160 hours ]
    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.

  2. tolerability [ Time Frame: 24 to 160 hours ]
    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).

  3. cost-effectiveness [ Time Frame: 24 to 160 hours ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135510


Locations
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Netherlands
Gemini Ziekenhuis Recruiting
Den Helder, Noord Holland, Netherlands, 1782 GZ
Contact: S.C.S. Tromp-van Driel    (0223) 69 69 69      
Tergooiziekenhuizen Recruiting
Hilversum, Noord Holland, Netherlands, 1213 XZ
Contact: H.P. van den Berg    088 753 17 53      
Medisch Centrum Alkmaar Recruiting
Alkmaar, Noord-Holland, Netherlands, 1815 JD
Contact: S Vrijaldenhoven    (072) 548 2870      
Ziekenhuis Amstelland Recruiting
Amstelveen, Noord-Holland, Netherlands, 1186 AM
Contact: A. van Zweeden    (020) 755 7000      
Waterland Ziekenhuis Not yet recruiting
Purmerend, Noord-Holland, Netherlands, 1441 RN
Contact: J Brakenhoff    0299 457 457      
De Heel - Zaans Medisch Centrum Not yet recruiting
Zaandam, Noord-Holland, Netherlands, 1502 DV
Contact: A. van Bochove    (075) 650 29 11      
Rijnstate Recruiting
Arnhem, Netherlands
Contact: T van Voorthuizen    +31(0)88 005 8888      
Sponsors and Collaborators
VU University Medical Center
Noordwest Ziekenhuisgroep
Rijnstate
Tergooiziekenhuizen locatie Hilversum
Ziekenhuis Amstelland

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Responsible Party: H.M.W. Verheul, Head Department Medical Oncology, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02135510     History of Changes
Other Study ID Numbers: 2011/366
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Palonosetron
Metoclopramide
Emetics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents