Abstract
Context
No clinical trials have examined the effect of netupitant/palonosetron (NEPA) on chronic
nausea in patients with cancer.
Objectives
In this pilot randomized trial, we assessed the efficacy of NEPA and placebo on chronic
nausea.
Methods
This double-blind, parallel, randomized trial enrolled patients with cancer and 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 between day 5 and 15.
Results
Among the 53 enrolled patients, 46 proceeded to placebo run-in and 33 had blinded
treatment (22 NEPA and 11 placebo). We observed a statistically significant within-group
improvement in nausea numeric rating scale between day 5 and 15 in the NEPA group
(mean change, −2.0; 95% CI, −3.1 to −0.8) and the placebo group (mean change, −2.3;
95% CI, −3.9 to −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
NEPA and placebo were associated with similar magnitude of within-group improvement
in chronic nausea without significant between-group differences (Clinicaltrials.gov NCT03040726).
Key Words
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Article info
Publication history
Published online: December 31, 2020
Accepted:
December 29,
2020
Identification
Copyright
© 2020 Published by Elsevier Inc. on behalf of American Academy of Hospice and Palliative Medicine.
