BACKGROUND No clinical trials have examined the effect of netupitant/palonosetron (NEPA) on chronic nausea in cancer patients. In this pilot randomized trial, we assessed the efficacy of NEPA and placebo… Click to show full abstract
BACKGROUND No clinical trials have examined the effect of netupitant/palonosetron (NEPA) on chronic nausea in cancer patients. In this pilot randomized trial, we assessed the efficacy of NEPA and placebo on chronic nausea. METHODS This double-blind, parallel, randomized trial enrolled cancer patients with chronic nausea for at least 1 month, intensity ≥4/10 and not on moderately or highly emetogenic systemic therapies. Patients started with a placebo run-in period from days 1 to 5; those without a placebo response proceeded to the double-blinded phase between days 6 to 15 (NEPA: placebo 2:1 ratio). The primary outcome was within-group change in average nausea over the 24 hours on a 0-10 numeric rating scale (NRS) between day 5 and 15. RESULTS Among the 53 enrolled patients, 46 proceeded to placebo run-in and 33 had blinded treatment (22 NEPA, 11 placebo). We observed a statistically significant within-group improvement in nausea NRS between day 5 and day 15 in the NEPA group (mean change -2.0, 95% CI -3.1,-0.8) and the placebo group (mean change -2.3, 95% CI -3.9, -0.7). A complete response was achieved in 8 (38%) patients in the NEPA group and 2 (20%) in the placebo group by day 15. No Grade 3-4 toxicities were attributed to NEPA. There were no statistically significant between-group differences for the primary/secondary outcomes. CONCLUSIONS Both NEPA and placebo were associated with similar magnitude of within-group improvement in chronic nausea without significant between-group differences. (Clinicaltrials.gov NCT03040726).
               
Click one of the above tabs to view related content.