Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin

November 4, 2010 updated by: Mahidol University

Randomized, Placebo-controlled Trial of Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis in Patients Receiving High Dose Cisplatin in Routine Medical Practice

The objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Division of medical oncology, department of medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • schedule to receive first cycle of cisplatin > 50 mg/m^2
  • pathologically or histologically confirmed solid cancer
  • more than 18 years old
  • creatinine clearance more than 50 ml/min
  • aminotransferase less than 2 times of upper normal limit

Exclusion Criteria:

  • pregnant woman
  • patients with episode of vomiting within 24 hours prior to chemotherapy session
  • gut obstruction
  • brain metastasis
  • abdominal or pelvic irradiation
  • no history of allergy to study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metoclopramide
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
Drug: metoclopramide
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg oral four times a day on day 2-5
Other Names:
  • plasil
Placebo Comparator: placebo
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5
Drug: placebo
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Had Complete Response
Time Frame: 5 days after receiving chemotherapy
number of patients who experience no emesis and need no rescue treatment in 5-day period
5 days after receiving chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicities and Severity of Nausea and Vomiting
Time Frame: 5 days after receiving chemotherapy
5 days after receiving chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Siriraj Hospital

Investigators

  • Principal Investigator: Suthinee Ithimakin, MD, Faculty of Medicine Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

December 2, 2010

Last Update Submitted That Met QC Criteria

November 4, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si094/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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