Ithimakin, S., Runglodvatana, K., Nimmannit, A., Akewanlop, C., Srimuninnimit, V., Keerativitayanan, N., . . . Laocharoenkeat, A. (2012). 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. Supportive Care in Cancer, 20, 849-855.doi: 10.1007/s00520-011-1162-4
To evaluate the effectiveness and safety of adding metoclopramide to the standard ondansetron and dexamethasone antiemetic regimen for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) among patients receiving cisplatin-based therapy
Patients were randomized (stratified by gender and age group) to a treatment or control group. All patients received ondansetron and dexamethasone prior to cisplatin and on the four subsequent days (days 2-5). Patients received either 20 mg of metoclopramide or placebo orally four times daily on days 2-5. Rescue treatment (including metoclopramide) was allowed based on the decision of the primary physician. On day 2, blinded data collectors documented the first emetic episode and frequency of emesis, severity of nausea and vomiting, side effects, and rescue antiemetic medications. On day 5, patients reported satisfaction of emetic treatment and quality of life.
The study was conducted at a single site, inpatient setting in Thailand.
All patients were in active antitumor treatment.
This was a randomized, double-blinded, placebo-controlled study.
No antiemetic benefit was found by adding metoclopramide to the standard ondansetron and dexamethasone regimen during cisplatin-based therapy; however, results are difficult to interpret because of a significant number of control patients receiving metoclopramide prior to the start of the study.
A high number of patients in the placebo group developed anticipatory vomiting prior to the start of treatment, which illustrates the importance of performing thorough assessments prior to the start of chemotherapy and providing education prior to the start of the next course of chemotherapy.