Khamales, S., Bethune-Volters, A., Chidiac, J., Bensaoula, O., Delgado, A., & Di Palma, M.. (2006). A randomized, double-blind trial assessing the efficacy and safety of sublingual metopimazine and ondansetron in the prophylaxis of chemotherapy-induced delayed emesis. Anticancer Drugs, 17(2), 217-224.

Study Purpose

To compare the efficacy and safety of sublingual metopimazine to ondansetron orally disintegrating tablet (ODT) in patients receiving highly emetogenic chemotherapy (HEC) for the prevention of delayed (not acute) chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Participants were randomized to one of two treatment arms. In group 1, patients received 7.5 mg sublingual metopimazine every eight hours on days 2–6, and, in group 2, patients received ODT ondansetron on days 2–6.

Sample Characteristics

  • The study consisted of 210 participants.
  • The sublingual metopimazine group had 103 patients, and the ODT ondansetron group had 97 patients.

Measurement Instruments/Methods

  • Patients recorded symptoms in daily diaries.
  • The Functional Living Index–Emesis (FLIE) was used.

Results

No significant differences were found between the two groups in control of delayed CINV, quality of life (QOL), or safety; however, control of delayed CINV was inferior compared to other studies.

Limitations

  • This study evaluated an “old” regimen that has since been considered suboptimal care per current consensus guidelines because of availability of newer, superior agents.
  • Corticosteroids were not allowed in the study.
  • The overall dose of metopimazine was low (ineffective).