• J Pain Symptom Manage · Aug 2021

    Randomized Controlled Trial

    Fixed-Dose Netupitant and Palonosetron for Chronic Nausea in Cancer Patients: A Double-Blind, Placebo Run-In Pilot Randomized Clinical Trial.

    • David Hui, Veronica Puac, Zeena Shelal, Diane Liu, Rama Maddi, Ahmed Kaseb, Milind Javle, Michael Overman, Sriram Yennurajalingam, Colleen Gallagher, and Eduardo Bruera.
    • Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.
    • J Pain Symptom Manage. 2021 Aug 1; 62 (2): 223232.e1223-232.e1.

    ContextNo clinical trials have examined the effect of netupitant/palonosetron (NEPA) on chronic nausea in patients with cancer.ObjectivesIn this pilot randomized trial, we assessed the efficacy of NEPA and placebo on chronic nausea.MethodsThis 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.ResultsAmong 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.ConclusionsNEPA and placebo were associated with similar magnitude of within-group improvement in chronic nausea without significant between-group differences (Clinicaltrials.gov NCT03040726).Copyright © 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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