• Support Care Cancer · Apr 2012

    Randomized Controlled Trial Comparative Study

    Randomized, double-blinded, placebo-controlled trial of ondansetron plus dexamethasone with or without metoclopramide as antiemetic prophylaxis in patients receiving high-dose cisplatin in medical practice.

    • Suthinee Ithimakin, Kanakorn Runglodvatana, Akarin Nimmannit, Charuwan Akewanlop, Vichien Srimuninnimit, Narong Keerativitayanan, Nopadol Soparattanapaisarn, and Apirom Laocharoenkeat.
    • Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand. aesi105@yahoo.co.th
    • Support Care Cancer. 2012 Apr 1;20(4):849-55.

    PurposesOndansetron plus dexamethasone are standard antiemetic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone. The objective of this study was to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.MethodsPatients who received ≥50 mg/m(2) of cisplatin for the first time were given intravenous ondansetron and dexamethasone on day 1 and were randomized to receive either standard antiemetics (ondansetron 8 mg orally bid on days 2-5 and dexamethasone 8 mg orally bid on days 2-4) plus metoclopramide 20 mg orally qid on days 2-5 or a placebo. The primary endpoint was a complete response (CR) rate defined as no emesis and no rescue treatment over a 120-h period. Secondary endpoints included severity of nausea and vomiting, time to first emesis, quality of life, and adverse effects.ResultsAmong 162 patients, 50 patients (60%) in the metoclopramide group and 42 patients (53%) in the control group achieved CR (p = 0.36). The mean times to first emesis in the metoclopramide and control groups were 88 and 75 h, respectively (p = 0.18). The degrees of nausea and vomiting in both groups were similar. Eleven patients (13%) in the metoclopramide group and 20 (25%) in the control group required rescue treatment (p = 0.05). Quality of life and adverse effects were not different between the two groups.ConclusionThe addition of metoclopramide to ondansetron plus dexamethasone reduced the use of rescue medication, but did not affect complete response rate, quality of life or adverse effects.

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