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

Mahidol University162 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

162

Conditions

Cancer

Interventions

metoclopramideDRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of medical oncology, department of medicine Siriraj Hospital

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

Number of Patients Who Had Complete Response

number of patients who experience no emesis and need no rescue treatment in 5-day period

Time frame: 5 days after receiving chemotherapy

Secondary Outcomes

Toxicities and Severity of Nausea and Vomiting

Time frame: 5 days after receiving chemotherapy

Data from ClinicalTrials.gov

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