EA 3738 - CICLy - Centre d'Innovation en Cancérologie de Lyon, UFR Faculté de Médecin Lyon-Sud-Charles Mérieux BP1, Université Claude Bernard Lyon 1, 165, Chemin du Grand Revoyet, 69921, Oullins Cedex, France.
Palliative Care Center, Hospices Civils de Lyon, 165, Chemin du Grand Revoyet, 69495, Pierre-Bénite, France.
BMC Palliat Care. 2022 May 23;21(1):84. doi: 10.1186/s12904-022-00976-7.
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.
晚期癌症患者通常同时存在多种症状。这可能导致多种药物治疗，并增加不良事件，对医疗保健质量构成重大威胁，尤其是在姑息治疗情况下。米氮平是一种抗抑郁药，已被提议作为一种潜在的相关药物，同时缓解多种与癌症相关的症状。因此，本研究旨在评估米氮平与另一种抗抑郁药艾司西酞普兰相比，在缓解同时患有重度抑郁症的晚期癌症患者多种症状方面的疗效。
在法国 12 个姑息治疗服务中心进行的多中心、前瞻性、随机、对照试验。该研究将采用混合方法学，使用平行组，口服米氮平与口服艾司西酞普兰进行比较，随访 56 天。主要结局指标为第 56 天的总体健康状况（来自 EORTC-QLQ-C30 量表）改善。将有 418 名参与者在第 7 天和第 56 天进行临床随访，并在第 14 天和第 28 天进行电话评估。将邀请部分参与者参加基线和第 56 天的半结构式定性访谈。对于定性部分，将采用目的性抽样。
这项研究将为晚期癌症患者多种症状的药物治疗管理提供证据。这可能会导致通过使用单一分子同时缓解多种症状，从而对这些患者的管理产生重要影响，从而提高药物的依从性，控制症状，并降低药物不良事件的风险。
试验注册：NCT04763135。注册日期：2021 年 3 月 18 日。
