ANTIEMETIC EFFICACY OF PREDNISOLONE - A PLACEBO-CONTROLLED TRIAL IN PATIENTS WITH ADVANCED PROSTATIC-CANCER TREATED WITH ESTRAMUSTINE PHOSPHATE

The antiemetic effect of prednisolone on nausea/vomiting was investiga ted in 67 patients with advanced prostatic cancer and a performance st atus of less than or equal to 2. The study was a double-blind, placebo -controlled, randomized trial with a parallel group design. The object ive was to compare the incidence and severity of nausea/vomiting betwe en the two groups. Prednisolone or placebo was given twice daily for 3 weeks with the dose decreased during the third week from 15 mg/day to 10 mg for 3 days and finally to 5 mg/day during the last 4 days. EMP was given as two 140 mg capsules daily for 3 days at the beginning, th en as four capsules for 4 days followed by six capsules for 21 days. A reas under curves (AUCs) for nausea and for nausea/vomiting scores wer e calculated based on the patient's diary notes: nausea (0-3), vomitin g (0-6), nausea/vomiting (0-9). Control of emesis in terms of complete , moderate or poor control was registered. Pretreatment characteristic s were evenly balanced. The results indicated that no statistical diff erences between the two groups of patients were present in AUCs for we eks 1-3 or weeks 1-4. We conclude that it was not possible to demonstr ate a significant antiemetic efficacy of prednisolone. However, in all but one case the patients in the prednisolone group could be treated for at least 3 weeks without any major incidents of nausea/vomiting.