What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol.
Advanced cancer
Antidepressive Agents
Cancer pain
Neoplasms
Palliative Care
Polysymptomatology
Signs and Symptoms
Journal
BMC palliative care
ISSN: 1472-684X
Titre abrégé: BMC Palliat Care
Pays: England
ID NLM: 101088685
Informations de publication
Date de publication:
23 May 2022
23 May 2022
Historique:
received:
23
04
2021
accepted:
11
05
2022
entrez:
22
5
2022
pubmed:
23
5
2022
medline:
25
5
2022
Statut:
epublish
Résumé
Advanced cancer patients often experience multiple symptoms at a same time. This might lead to polypharmacy and increase adverse events representing major threats to the quality of health care, especially in palliative care situations. Mirtazapine, an antidepressant agent, has been suggested as a potential relevant drug to alleviate multiple cancer-related symptoms at a same time. Therefore, the present study aims to assess the effectiveness of mirtazapine in alleviating multiple symptoms at a same time in advanced cancer patients suffering from a major depressive episode compared to a group receiving escitalopram, another antidepressant agent. Multicentre, prospective, randomized, controlled trial in 12 palliative care services in France. The study will be based on a mixed-method methodology using parallel groups, of oral mirtazapine compared with oral escitalopram, with a 56 day follow-up. The primary outcome will be an improvement of the Global health Status (issued from the EORTC-QLQ-C30) on day 56. 418 participants will be clinically followed-up on day 7 and 56 and will have a telephonic assessment on days 14 and 28. A sub-sample of participants will be invited to take part in semi-structured qualitative interviews at baseline and day 56. For the qualitative part, purposeful sampling will be used. This study will provide evidence for the pharmaceutics management of poly-symptomatology in advanced cancer patients. This could lead to important changes in the management of those patients by using a single molecule to alleviate multiple symptoms at a same time, potentially improving medication adherence, symptoms' control, and reducing the risk of medications adverse events. Trial registration: NCT04763135 . Registered 18 March 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Advanced cancer patients often experience multiple symptoms at a same time. This might lead to polypharmacy and increase adverse events representing major threats to the quality of health care, especially in palliative care situations. Mirtazapine, an antidepressant agent, has been suggested as a potential relevant drug to alleviate multiple cancer-related symptoms at a same time. Therefore, the present study aims to assess the effectiveness of mirtazapine in alleviating multiple symptoms at a same time in advanced cancer patients suffering from a major depressive episode compared to a group receiving escitalopram, another antidepressant agent.
METHODS
METHODS
Multicentre, prospective, randomized, controlled trial in 12 palliative care services in France. The study will be based on a mixed-method methodology using parallel groups, of oral mirtazapine compared with oral escitalopram, with a 56 day follow-up. The primary outcome will be an improvement of the Global health Status (issued from the EORTC-QLQ-C30) on day 56. 418 participants will be clinically followed-up on day 7 and 56 and will have a telephonic assessment on days 14 and 28. A sub-sample of participants will be invited to take part in semi-structured qualitative interviews at baseline and day 56. For the qualitative part, purposeful sampling will be used.
DISCUSSION
CONCLUSIONS
This study will provide evidence for the pharmaceutics management of poly-symptomatology in advanced cancer patients. This could lead to important changes in the management of those patients by using a single molecule to alleviate multiple symptoms at a same time, potentially improving medication adherence, symptoms' control, and reducing the risk of medications adverse events.
TRIAL REGISTRATION
BACKGROUND
Trial registration: NCT04763135 . Registered 18 March 2021.
Identifiants
pubmed: 35599320
doi: 10.1186/s12904-022-00976-7
pii: 10.1186/s12904-022-00976-7
pmc: PMC9125889
doi:
Substances chimiques
Antidepressive Agents
0
Escitalopram
4O4S742ANY
Mirtazapine
A051Q2099Q
Banques de données
ClinicalTrials.gov
['NCT04763135']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
84Subventions
Organisme : Direction Générale de l'offre de Soins
ID : PHRCI-19-073
Informations de copyright
© 2022. The Author(s).
Références
Support Care Cancer. 2011 Nov;19(11):1753-60
pubmed: 20886240
Br J Cancer. 2001 Nov 16;85(10):1478-85
pubmed: 11720432
Onco Targets Ther. 2014 May 08;7:687-95
pubmed: 24855379
CNS Drug Rev. 2001 Fall;7(3):249-64
pubmed: 11607047
Support Care Cancer. 2008 Nov;16(11):1291-8
pubmed: 18299900
Trials. 2014 Nov 21;15:456
pubmed: 25416527
Cancer J. 2017 Jul/Aug;23(4):211-218
pubmed: 28731943
Expert Rev Respir Med. 2019 Feb;13(2):173-180
pubmed: 30596298
Ann Oncol. 2018 Jan 1;29(1):36-43
pubmed: 29253069
Med Care. 2013 Aug;51(8 Suppl 3):S11-21
pubmed: 23774515
Support Care Cancer. 2016 May;24(5):2067-2074
pubmed: 26542274
J Clin Psychiatry. 2004;65 Suppl 4:46-52
pubmed: 15046541
J Clin Oncol. 2011 Jan 1;29(1):89-96
pubmed: 21098316
Cancer. 2015 Sep 1;121(17):3027-35
pubmed: 26059846
Am J Hosp Palliat Care. 2010 Mar;27(2):106-10
pubmed: 19776373
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
J Pain Symptom Manage. 2007 Jul;34(1):94-104
pubmed: 17509812
Support Care Cancer. 2020 Apr;28(4):1597-1606
pubmed: 31858251
Support Care Cancer. 2009 Sep;17(9):1223-30
pubmed: 19184126
Support Care Cancer. 2012 Dec;20(12):3307-13
pubmed: 22562607
Psychother Psychosom. 2016;85(5):270-88
pubmed: 27508501
J Clin Epidemiol. 1997 Apr;50(4):441-50
pubmed: 9179103
Cochrane Database Syst Rev. 2017 Jun 12;6:CD011129
pubmed: 28603881
Curr Med Res Opin. 2008 May;24(5):1329-35
pubmed: 18377706
Eur J Cancer. 2012 Jul;48(11):1713-21
pubmed: 22418017
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
Health Qual Life Outcomes. 2008 Jul 02;6:46
pubmed: 18597689
Eur J Cancer. 1997 Jun;33(7):1025-30
pubmed: 9376182