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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: metoclopramide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metoclopramide<br>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<br>* 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<br>* Other names: plasil;|
| Placebo Comparator: placebo<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Had Complete Response | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities and Severity of Nausea and Vomiting |  | 5 days after receiving chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy induced nausea and vomiting, metoclopramide