Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial.
机构:[1]Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital (HKU-SZH), Shenzhen, Guangdong, China.深圳市康宁医院深圳医学信息中心香港大学深圳医院[2]School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.[3]Department of Clinical Oncology, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.[4]Department of Clinical Oncology, Hong Kong Sanatorium Hospital, Hong Kong, China.[5]School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.[6]Department of Psychiatry, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.[7]Department of Statistics and Actuarial Science, The University of Hong Kong, Hong Kong, China.[8]Virginia University of Integrative Medicine, Fairfax, Virginia, USA.
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.
基金:
The author(s) disclosed receipt of the following financial support
for the research, authorship, and/or publication of this article: This
trial is funded by National Key R&D Program of China (Ref no:
2018YFC1705801), and Health and Medical Research Fund,
Government of the Hong Kong Special Administrative Region of
China Health and Medical Research Fund (Ref no: 16172761).
第一作者机构:[1]Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital (HKU-SZH), Shenzhen, Guangdong, China.[2]School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
通讯作者:
通讯机构:[1]Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital (HKU-SZH), Shenzhen, Guangdong, China.[2]School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.[8]Virginia University of Integrative Medicine, Fairfax, Virginia, USA.[*1]School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong, China[*2]Virginia University of Integrative Medicine, 9401 Mathy Drive, Fairfax, VA 22031, USA.
推荐引用方式(GB/T 7714):
Zhang Jialing,Yang Mingxiao,So Tsz Him,et al.Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial.[J].INTEGRATIVE CANCER THERAPIES.2021,20:doi:10.1177/15347354211058695.
APA:
Zhang Jialing,Yang Mingxiao,So Tsz Him,Chang Tien Yee,Qin Zongshi...&Zhang Zhang-Jin.(2021).Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial..INTEGRATIVE CANCER THERAPIES,20,
MLA:
Zhang Jialing,et al."Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial.".INTEGRATIVE CANCER THERAPIES 20.(2021)