Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital (HKU-SZH), Shenzhen, Guangdong, China.
School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Integr Cancer Ther. 2021 Jan-Dec;20:15347354211058695. doi: 10.1177/15347354211058695.
Insomnia is a highly prevalent and disturbing symptom in breast cancer patients under or post chemotherapy. If not appropriately treated, it can persist for years after the completion of cancer treatments. Acupuncture has been widely used for alleviating insomnia. The aim of this study is to examine the feasibility, efficacy and safety of acupuncture for chemotherapy-related insomnia among patients with breast cancer.
This is a trial protocol for a randomized, sham-controlled, subject- and assessor-blinded clinical trial. A total of 138 eligible participants will be assigned randomly to acupuncture or sham control group at a ratio of 1:1. Participants in acupuncture group will receive electroacupuncture (EA) plus auricular acupressure (AA) treatment, while subjects in sham acupuncture group will receive sham EA plus sham AA. Both acupuncture and sham treatments will be given twice weekly for 6 weeks, followed by maintenance treatments once every 4 weeks for 12 weeks (15 sessions totally). The primary outcome is the change of Insomnia Severity Index score between baseline and the end of 6-week treatment. Secondary outcome measurements include Actiwatch, sleep diary, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy-Breast Cancer, Hospital Anxiety and Depression Scale, Brief Pain Inventory-Short Form, Brief Fatigue Inventory, Acupuncture Expectancy Scale, credibility, and adverse events. Participants will be followed up to 42 weeks.
This trial will expand our understanding of the feasibility, efficacy, and safety of acupuncture as a treatment for alleviating chemotherapy-related insomnia in patients with breast cancer. EA plus AA, if proven to be effective, can be implemented into routine settings to play a role in insomnia management for patients with breast cancer.
失眠是乳腺癌患者化疗期间或化疗后常见且令人困扰的症状。如果未得到适当治疗，其可能会在癌症治疗结束后持续多年。针灸已广泛用于缓解失眠。本研究旨在评估针灸治疗乳腺癌患者化疗相关性失眠的可行性、疗效和安全性。
这是一项随机、假对照、患者和评估者双盲临床试验的试验方案。共有 138 名符合条件的参与者将按照 1:1 的比例随机分配至针灸组或假针灸组。针灸组将接受电针（EA）加耳穴按压（AA）治疗，而假针灸组将接受假 EA 加假 AA。针灸和假针灸治疗均每周 2 次，持续 6 周，然后每 4 周维持治疗 12 周（共 15 次）。主要结局是基线和 6 周治疗结束时失眠严重程度指数评分的变化。次要结局测量包括活动监测仪、睡眠日记、匹兹堡睡眠质量指数、癌症治疗功能评估-乳腺癌、医院焦虑和抑郁量表、简明疼痛量表-短表、简明疲劳量表、针灸期望量表、可信度和不良事件。参与者将随访 42 周。
本试验将扩大我们对针灸治疗乳腺癌患者化疗相关性失眠的可行性、疗效和安全性的理解。如果 EA 加 AA 被证明有效，它可以被纳入常规治疗方案，在乳腺癌患者的失眠管理中发挥作用。
