The University of Hong Kong, Hong Kong, China.
Queen Elizabeth Hospital, Hong Kong, China.
Integr Cancer Ther. 2021 Jan-Dec;20:15347354211012749. doi: 10.1177/15347354211012749.
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.
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.
Clinicaltrials.gov, NCT04398875 (https://www.clinicaltrials.gov/ct2/show/NCT04398875), Registered on 21 May 2020.
癌症是 70 岁以下人群的第二大死亡原因。癌症生存率的提高对癌症护理提出了更高的要求。姑息治疗是一种专门的多学科护理，旨在缓解严重疾病的疼痛、症状和压力。本研究旨在评估姑息治疗协作模式下针刺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。将 120 名接受姑息治疗的晚期癌症患者按 2:1:1 的比例随机分为针刺加标准护理组（ASC）、假针刺加标准护理组（SSC）和标准护理组（SC）。ASC 和 SSC 组患者将接受 9 次针刺或假针刺治疗，持续 3 周，并随访 2 个月。主要指标是 3 周时 Edmonton 症状评估系统基线评分的变化。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、数字评分量表以及欧洲癌症研究与治疗组织 15 项生活质量问卷（姑息治疗）。
该试验的结果将为姑息治疗中针刺辅助标准护理对晚期癌症患者的辅助作用提供高质量的证据。
Clinicaltrials.gov，NCT04398875（https://www.clinicaltrials.gov/ct2/show/NCT04398875），注册于 2020 年 5 月 21 日。
