Antiemetic efficacy of high-dose dexamethasone versus placebo in patients receiving cisplatin-based chemotherapy: A randomized double-blind controlled clinical trial

The antiemetic effect of short courses of high-dose dexamethasone was compared with that of placebo in 64 patients receiving cisplatin-based cancer chemotherapy, in a double-blind randomized clinical trial. All patients were receiving cisplatin for the first time. Dexamethasone was given intravenously (IV) at a dose of 20 mg, two hours before and 3, 6, 9, and 12 hours after chemotherapy. Patients were crossed over to dexamethasone on the second cycle of chemotherapy if they experienced unacceptable gastrointestinal (GI) toxicity after initial treatment with placebo. Nine of 32 patients receiving dexamethasone and seven of 32 patients receiving placebo did not vomit. The median duration of nausea was significantly shorter (one-half hour) for the dexamethasone-treated group compared with that of placebo (3 1/2 hours). The number of patients who experienced unacceptable GI toxicity was significantly greater (53%) for the placebo patients than for those treated with dexamethasone (25%). Patients crossing over to dexamethasone after initially receiving placebo had a median duration of nausea of 1 1/2 hours and 24% did not vomit, results comparable to the first treatment group. We conclude that high-dose dexamethasone is only minimally effective as an antiemetic agent in patients receiving cisplatin-based chemotherapy.