Clinical Studies| Volume 17, ISSUE 6, P1091-1098, November 1995

Download started.


Ondansetron for nausea and vomiting associated with moderately emetogenic cancer chemotherapy

      This paper is only available as a PDF. To read, Please Download here.


      This multicenter, randomized, double-blind study compared the efficacy and tolerability of ondansetron 8 mg twice daily for 3 days with placebo in preventing nausea and vomiting in 81 patients receiving cyclophosphamide-doxorubicin—based chemotherapy. The first dose of study drug was administered 30 minutes before the initiation of chemotherapy. Patients received a rescue antiemetic if the investigation deemed it necessary or if the patient experienced more than two emetic episodes during the 3-day study. Sixty-one percent of patients treated with ondansetron compared with 6% of patients receiving placebo (P < 0.001) had no emetic episodes during the 3-day study. Among patients with at least one emetic episode, the mean time to emesis was 24 hours 18 minutes in the ondansetron group compared with 8 hours 1 minute in the placebo group (P < 0.001). In the intent-to-treat analysis, 78% of patients in the ondansetron group and 29% of patients in the placebo group completed the study with no need for rescue therapy. Clinical laboratory and adverse-event profiles were similar between groups. The most common adverse event was headache, occurring in 23% of ondansetron patients and 24% of placebo patients. This study is the first double-blind, placebo-controlled trial to demonstrate that ondansetron 8 mg twice daily is effective in the prevention of nausea and vomiting associated with cyclophosphamide-doxorubicin—based chemotherapy. The twice-daily regimen may encourage patient compliance and may be more cost-effective than rergimens that need to be given three times daily.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Clinical Therapeutics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Coates A
        • Abraham S
        • Kaye SB
        • et al.
        On the receiving end—patient perception of the side-effects of cancer chemotherapy.
        Eur J Cancer Clin Oncol. 1983; 19: 203-208
        • Sagar SM
        The current role of anti-emetic drugs in oncology: A recent revolution in patient symptom control.
        Cancer Treat Rev. 1991; 18: 95-135
        • Kovac AL
        Use of serotonin receptor antagonists in the prevention and treatment of nausea and vomiting.
        Hosp Formul. 1993; 28: 988-998
        • Beck TM
        • Ciociola AA
        • Jones SE
        • et al.
        Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy.
        Ann Intern Med. 1993; 118: 407-413
        • Beck TM
        Efficacy of ondansetron tablets in the management of chemotherapy-induced emesis: Review of clinical trials.
        Semin Oncol. 1992; 19 (Suppl 15): 20-25