Prospective randomized double-blind trial of nabilone versus domperidone in the treatment of cytotoxic-induced emesis |
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Authors: | Mauve Pomeroy James J. Fennelly Mark Towers |
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Affiliation: | (1) Department of Clinical Oncology, St. Vincent's Hospital, Elm Park, Dublin 4, Eire;(2) Meath Hospital, Dublin, Eire |
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Abstract: | Summary A prospective randomized double-blind trial comparing the butyrophenone analogue domperidone (D) and the synthetic cannabinoid nabilone (N) in the treatment of cytotoxic-induced emesis was conducted in 38 patients receiving highly emetogenic chemotherapy regimens (70% containing cisplatin). Patients received 20 mg D or 1 mg N the night before chemotherapy and 8-hourly on each chemotherapy day for two consecutive cycles of treatment.Three of 19 patients randomized to N completed only one cycle because of disease progression (2) or subjectively adverse effects (1). Four of 19 patients completed only one cycle of D because of lack of efficacy (3) or chemotherapy toxicity (1). In all, 32 cycles of N and 33 cycles of D were evaluable for efficacy. The mean number of vomiting episodes in cycle 1 was 4.76 for N and 12.95 for D (P<0.02). The corresponding values for cycle 2 were 4.27 and 7.69 (P>0.10), and for cycles 1 and 2 combined, 4.53 for N and 10.81 for D (P<0.01). Nausea and food intake scores did not differ significantly, although there was a trend towards less nausea and an increased food intake with N. Subjectively adverse effects were more frequent with N and included drowsiness, dizziness, dry mouth, and postural hypotension. N is superior to D for the control of cytotoxic-induced emesis. |
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