Original article: Double-blind, randomized trial for the control of delayed emesis in patients receiving cisplatin: Comparison of placebo vs. adrenocorticotropic hormone (ACTH)

Abstract

Summary: Delayed nausea and vomiting is a significant problem for the majority of patients receiving cisplatin. We designed a double-blind randomized study comparing the effects of ACTH and placebo on delayed emesis. Sixty-four adult cancer patients entered this trial; all received a chemotherapy regimen containing cisplatin (≥60mg/m2) and a combination of metoclopramide and dexamethasone for the control of acute emesis during the period from 0 to 24 h after cisplatin (day 1). Twenty-four hours after cisplatin (day2) they were randomized to received 1 mg of ACTH i.m. in its long-acting form, or placebo in an identical vial. All patients were asked to keep a daily record of the incidence and severity of delayed vomiting and nausea for each of the five consecutive 24-h periods after cisplatin administration. Sixty patients were evaluable. The percentages of patients experiencing vomiting in the ACTH and placebo arms were, respectively, 17% vs. 43% on day 2(24-48 h after cisplatin)(P=0.04), 13%vs. 40% on day 3(48-72h) (P=0.04), 20% vs. 34% on day 4(72-96h), and 20% vs. 30% on day 5(96-120h). During the entire 5-day study period, 33% of the patients in the ACTH group experienced delayed vomiting as opposed to 57% in the placebo arm (P-0.11). With regard to the severity of delayed vomiting it was observed that the patients treated with ACTH had a significant reduction in the number of emetic episodes on day 2(p-0.01) and day 3(P=0.03) as well as throughout the entire 5-day study period (P=0.04). No statistically significant differences were observed between the two arms with regard to the incidence and severity of delayed nausea. No. treatment-related side effects were reported. Our results show that 1 mg of ACTH is safe, well-tolerated and reduces the incidence and severity of delayed vomiting, particularly on days 2 and 3 (24-72h) after cisplatin. On the succeeding days there was a loss of activity, and further studies with repeated doses of ACTH are needed for prolongation of the period of protection. © 1992 Kluwer Academic Publishers.