Melatonin to prevent delirium in patients with advanced cancer: a double blind, parallel, randomized, controlled, feasib
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RESEARCH ARTICLE
Open Access
Melatonin to prevent delirium in patients with advanced cancer: a double blind, parallel, randomized, controlled, feasibility trial Peter G. Lawlor1,2,3,4* , Marie T. McNamara-Kilian2, Alistair R. MacDonald2, Franco Momoli5, Sallyanne Tierney4, Nathalie Lacaze-Masmonteil3, Monidipa Dasgupta6, Meera Agar7, Jose L. Pereira8, David C. Currow7 and Shirley H. Bush1,2,3,4
Abstract Background: Delirium is highly problematic in palliative care (PC). Preliminary data indicate a potential role for melatonin to prevent delirium, but no randomized controlled trials (RCTs) are reported in PC. Methods: Patients aged ≥18 years, with advanced cancer, admitted to an inpatient Palliative Care Unit (PCU), having a Palliative Performance Scale rating ≥ 30%, and for whom consent was obtained, were included in the study. Patients with delirium on admission were excluded. The main study objectives were to assess the feasibility issues of conducting a double-blind RCT of exogenous melatonin to prevent delirium in PC: recruitment, retention, procedural acceptability, appropriateness of outcome measures, and preliminary efficacy and safety data. Study participants were randomized in a double-blind, parallel designed study to receive daily melatonin 3 mg or placebo orally at 21:00 over 28 days or less if incident delirium, death, discharge or withdrawal occurred earlier. Delirium was diagnosed using the Confusion Assessment Method. Efficacy endpoints in the melatonin and placebo groups were compared using time-to-event analysis: days from study entry to onset of incident delirium. (Continued on next page)
* Correspondence: [email protected] Presented in part at 15th World Research Congress of the European Association for Palliative Care (EAPC), Madrid, Spain, May 18-20th 2017. 1 Division of Palliative Care, Department of Medicine, University of Ottawa, 43 Bruyère Street, Ottawa, ON K1N 5C8, Canada 2 Bruyère Research Institute, Ottawa, Canada Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in
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