Trial reportJournal of pain and symptom management2021
Fixed-Dose Netupitant and Palonosetron for Chronic Nausea in Cancer Patients: A Double-Blind, Placebo Run-in Pilot Randomized Clinical Trial.
Trial report in Journal of pain and symptom management, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03040726 (Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- MASCC antiemetics in advanced cancer updated guideline.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Guideline
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 1 institution in 1 country.
Funding
Abstract
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).
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Registered trials
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