title: 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.
abstract: OBJECTIVE
  Ondansetron 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.
  
  
  METHODS
  Patients 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.
  
  
  RESULTS
  Among 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand. aesi105@yahoo.co.th
authors.forename: Suthinee
authors.initials: S
authors.lastname: Ithimakin
authors.forename: Kanakorn
authors.initials: K
authors.lastname: Runglodvatana
authors.forename: Akarin
authors.initials: A
authors.lastname: Nimmannit
authors.forename: Charuwan
authors.initials: C
authors.lastname: Akewanlop
authors.forename: Vichien
authors.initials: V
authors.lastname: Srimuninnimit
authors.forename: Narong
authors.initials: N
authors.lastname: Keerativitayanan
authors.forename: Nopadol
authors.initials: N
authors.lastname: Soparattanapaisarn
authors.forename: Apirom
authors.initials: A
authors.lastname: Laocharoenkeat
mesh_terms: D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D012720:Severity of Illness Index; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D017294:Ondansetron; D003907:Dexamethasone; D008787:Metoclopramide; D002945:Cisplatin