Background:

Cancer is the second leading cause of death before the age of 70. Improved cancer survival has put increasing demands on cancer care. Palliative care is the specialized multi-disciplinary care providing relief from the pain, symptoms, and stress of serious illness. The study aims to evaluate the adjunctive effect of acupuncture for advanced cancer patients in a collaborative model of palliative care.

Methods/Design:

This is a single-blinded, randomized, sham-controlled trial. One hundred twenty advanced cancer patients undergoing palliative care will be randomized in a ratio of 2:1:1 to manual acupuncture plus standard care group (ASC), sham acupuncture plus standard care group (SSC), and standard care group (SC). Patients in ASC and SSC will receive 9 sessions of acupuncture or sham acupuncture for 3 weeks, and will be followed up for 2 months. The primary measure is the change from baseline score of the Edmonton Symptom Assessment System at 3 weeks. The secondary measures include the Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Insomnia Severity Index, Numeric Rating Scale, and European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care.

Discussion:

The finding of this trial will provide high-quality evidence on the adjunctive effect of acupuncture to standard care on advanced cancer patients undergoing palliative care.

Trial Registration:

Clinicaltrials.gov, NCT04398875 (https://www.clinicaltrials.gov/ct2/show/NCT04398875), Registered on 21 May 2020.

中文翻译：

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针灸在姑息治疗协作模型中对晚期癌症患者的辅助作用：3 臂随机试验的研究方案

背景：

癌症是 70 岁之前死亡的第二大原因。提高癌症存活率对癌症护理提出了越来越高的要求。姑息治疗是专业的多学科护理，可缓解严重疾病的疼痛、症状和压力。该研究旨在评估针灸在姑息治疗协作模式中对晚期癌症患者的辅助作用。

方法/设计：

这是一项单盲、随机、假对照试验。120 名接受姑息治疗的晚期癌症患者将按 2:1:1 的比例随机分配到手法针刺加标准治疗组 (ASC)、假针刺加标准治疗组 (SSC) 和标准治疗组 (SC)。ASC 和 SSC 的患者将接受 9 次针灸或假针灸治疗，为期 3 周，随访 2 个月。主要衡量指标是埃德蒙顿症状评估系统在 3 周时与基线评分相比的变化。次要指标包括简要疲劳量表、医院焦虑和抑郁量表、失眠严重程度指数、数字评定量表和欧洲癌症研究和治疗组织的生活质量 15 项姑息治疗问卷。

讨论：

该试验的发现将为接受姑息治疗的晚期癌症患者提供标准治疗的辅助作用的高质量证据。

试用注册：

Clinicaltrials.gov，NCT04398875 (https://www.clinicaltrials.gov/ct2/show/NCT04398875)，2020 年 5 月 21 日注册。