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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Drug: metoclopramide; Drug: placebo

• Registration Number: NCT01093690
• Lead Sponsor: Mahidol University

Brief Summary

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.

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-26
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Results First Submitted: 2010-10-10
• Status Verified: 2010-11
• Results First Submitted QC: 2010-11-04
• Last Update Submitted: 2010-11-04
• Results First Posted: 2010-12-02
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metoclopramide	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
placebo	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

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Had Complete Response	5 days after receiving chemotherapy	number of patients who experience no emesis and need no rescue treatment in 5-day period

Secondary Outcome Measures

Name	Time	Method
Toxicities and Severity of Nausea and Vomiting	5 days after receiving chemotherapy

Trial Locations

Locations (1)

Division of medical oncology, department of medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand