Amitriptyline plus fluphenazine to prevent chemotherapy-induced emesis in cancer patients: a double-blind randomized cross-over study.

In a population of 51 ambulant cancer patients treated with doxorubicin-containing chemotherapy we conducted a double-blind cross-over randomized trial, comparing the anti-emetic efficacy of a combination of amitriptyline (25 mg p.o. q 6 hr X 4) and fluphenazine (2.5 mg p.o. q 6 hr X 4) (AF) with that of metoclopramide (20 mg q 6 hr X 4) (M). Thirty-three out of the 51 patients vomited less than six times during treatment with AF as opposed to 26/51 with M. This difference was not significant. However, 55% of patients preferred AF to M, compared to 30% with the reverse preference (P less than 0.1). The main side-effect was drowsiness, which patients reported significantly more frequently when on AF. With both anti-emetic regimens men vomited less frequently than women. The combination of amitriptyline and fluphenazine, though theoretically attractive, did not appear to be an effective anti-emetic regimen in the dose and schedule given.

RCT Entities:   Population Interventions Outcomes