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A randomized open-label study of guideline-driven antiemetic therapy versus single agent antiemetic therapy in patients with advanced cancer and nausea not related to anticancer treatment

Hardy, Janet; Skerman, Helen; Glare, Paul; Philip, Jennifer; Hudson, Peter; Mitchell, Geoffrey; Martin, Peter; Spruyt, Odette; Currow, David; Yates, Patsy


Janet Hardy

Helen Skerman

Paul Glare

Jennifer Philip

Peter Hudson

Geoffrey Mitchell

Peter Martin

Odette Spruyt

David Currow

Patsy Yates


© 2018 The Author(s). Background: Nausea/vomiting (N/V) not related to anti-cancer treatment is common in patients with advanced cancer. The standard approach to management is to define a dominant cause, and treat with an antiemetic selected through pathophysiologic knowledge of emetic pathways. High rates of N/V control have been reported using both etiology-based guideline-driven antiemetic regimens and an empiric approach using single agents in uncontrolled studies. These different approaches had never been formally compared. Methods: This randomized, prospective, open label, dose-escalating study used readily available antiemetics in accordance with etiology-based guidelines or single agent therapy with haloperidol. Participants had a baseline average nausea score of ≥3/10. Response was defined as a ≥ 2/10 point reduction on a numerical rating scale of average nausea score with a final score < 3/10 at 72 h. Results: Nausea scores and distress from nausea improved over time in the majority of the 185 patients randomized. For those who completed each treatment day, a greater response rate was seen in the guideline arm than the single agent arm at 24 h (49% vs 32%; p = 0.02), but not at 48 or 72 h. Response rates at 72 h in the intention to treat analysis were 49 and 53% respectively, with no significant difference between arms (0.04; 95% CI: -0.11, 0.19; p = 0.59). Over 80% of all participants reported an improved global impression of change. There were few adverse events worse than baseline in either arm. Conclusion: An etiology-based, guideline-directed approach to antiemetic therapy may offer more rapid benefit, but is no better than single agent treatment with haloperidol at 72 h. Clinical trial registration: Australian New Zealand Clinical.


Hardy, J., Skerman, H., Glare, P., Philip, J., Hudson, P., Mitchell, G., …Yates, P. (2018). A randomized open-label study of guideline-driven antiemetic therapy versus single agent antiemetic therapy in patients with advanced cancer and nausea not related to anticancer treatment. BMC Cancer, 18(1), Article 510.

Journal Article Type Article
Acceptance Date Apr 18, 2018
Online Publication Date May 2, 2018
Publication Date 2018-12
Deposit Date Jun 3, 2020
Publicly Available Date Jun 8, 2020
Journal BMC Cancer
Print ISSN 1471-2407
Electronic ISSN 1471-2407
Publisher BioMed Central
Peer Reviewed Peer Reviewed
Volume 18
Issue 1
Article Number 510
Keywords Genetics; Cancer Research; Oncology
Public URL
Publisher URL
Additional Information Received: 1 December 2017; Accepted: 18 April 2018; First Online: 2 May 2018; : The study was approved by Human Research Ethics Committees at all sites: Alfred Hospital Ethics Committee (Victoria lead), Hunter New England Human Research Ethics Committee (NSW lead), Mater Health Services Human Research Ethics Committee, Southern Adelaide Clinical Research Ethics Committee, St. Vincent’s Health & Aged Care, Queensland University of Technology. All participants signed an approved Patient Information and Consent Form.; : All authors report the NHMRC Grant Funding. JH declares participation in medical advisory boards of MundiPharma Pty Ltd. and Menarini Ltd. Australia. OS declares advisory board consulting fees for Teva Pharmaceutical.; : Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.


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Copyright Statement
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

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