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A Multi-Institutional Phase III Study Of Nabilone Vs. Placebo In Chemotherapy-Induced

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A prospective, randomized, double-blind, crossover study of nabilone versus placebo was undertaken in three university cancer centers to determine the antiemetic efficacy and toxicity of nabilone in patients experiencing nausea and vomiting due to cancer chemotherapy. Identical study drug (2 mg of nabilone or placebo) was given the evening before and the morning of chemotherapy and for at least 24h afterwards on a b.i.d. schedule. Careful assessment of nausea, vomiting and finally patient preference for study drug was carried out on each of two identical courses of combination chemotherapy. Fifty-four patients were entered. Of the 24 patients fully evaluable for efficacy, nabilone significantly reduced the mean number of vomiting episodes (7 vs. 18, P<0.001) and nausea (P<0.001) compared to placebo. In addition, 79% of patients experienced less vomiting and 63% less nausea while receiving nabilone compared to 13 and 4% of patients reporting less with placebo. Sixty-seven percent of patients preferred nabilone at the completion of this trial compared to 8" for placebo (P<0.001). Side effects were common with nabilone but acceptable and in 49 patients who were evaluable for toxicity consisted primarily of dizziness (65%), drowsiness (51%), dry mouth (31%), sleep disturbance (14%), ataxia (8%), nausea (8%) and euphoria (6%). Nabilone is an effective antiemetic agent for chemotherapy-induced nausea and vomiting.

Source: Clinical Studies and Case Reports
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