Neurological mechanism and efficacy of acupuncture for breast cancer-related insomnia: a study protocol for randomized clinical trial

Lumin Liu; Ping Yin; Yiyue Dong; Qian Fan; Yisheng Huai; Shijie Zhang; Shunyi Lv; Xueyang Wang; Yuelai Chen

doi:10.3389/fneur.2023.1278564

Neurological mechanism and efficacy of acupuncture for breast cancer-related insomnia: a study protocol for randomized clinical trial

Front Neurol. 2023 Dec 22:14:1278564. doi: 10.3389/fneur.2023.1278564. eCollection 2023.

Authors

Lumin Liu^#¹, Ping Yin^#¹, Yiyue Dong¹, Qian Fan¹, Yisheng Huai¹, Shijie Zhang¹, Shunyi Lv¹, Xueyang Wang¹, Yuelai Chen¹

Affiliation

¹ LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China.

^# Contributed equally.

Abstract

Background: Breast cancer survivors (BCSs) are at a higher risk of developing insomnia. The negative effects of cancer-related insomnia (CRI) include depression, anxiety, fatigue, aggressive pain, impaired immune functioning, decreased quality of life, and even increased cancer mortality. Although preliminary progress has been made in the treatment of CRI with acupuncture, the evidence is insufficient and the neurological mechanism underlying the effect of acupuncture is still unclear.

Methods: The study employs a single-blinded, randomized, controlled trial design. A total of 80 participants will be randomly allocated in a 1:1 ratio to either the treatment group (n = 40) or the control group (n = 40). The former will receive acupuncture treatment, while the latter will receive sham acupuncture treatment. Both groups will receive 12 sessions over a 4-week period, three times per week (every other day), and each session will last for 30 min. Follow-up assessments will be conducted in week 8. The primary outcome will be the treatment response rate. Secondary outcomes include the change in Insomnia Severity Index (ISI), the treatment remission rate, actigraphy sleep assessment, Generalized Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Quality of Life Core Scale (QLQ-C30), the weekly usage of remedial drugs, and functional magnetic resonance imaging (fMRI) analysis. Data for the outcomes will be collected at week 0 (the baseline), week 1 (the intervention period), week 4 (the post-treatment period), and week 8 (the follow-up period).

Discussion: The objective of this study is to assess the efficacy of acupuncture for patients with CRI in comparison with sham acupuncture. Additionally, the research aims to explore the neuropathological mechanisms of CRI and provide the first evidence on the characteristics of acupuncture treatment using fMRI. We expect that the results of this study will provide valuable scientific evidence of acupuncture treatment for CRI.Clinical trial registration: Chinese Clinical Trial Registry, identifier ChiCTR2300070349: https://www.chictr.org.cn/showproj.html?proj=188677.

Keywords: acupuncture; breast cancer; fMRI; insomnia; protocol; randomized controlled trial.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was supported by the Clinical Incubation Program of the National Medical Center of LongHua Hospital SHUTCM (GY202201). Additionally, it was funded by the Shanghai Shenkang Hospital Development Center demonstration research ward construction project (SHDC2022CRW006), the Shanghai Famous Old Chinese Medicine Experts Academic Experience Research Studio Construction Project (SHGZS-202232), and The Shanghai Municipal Health Commission Health Industry Clinical Research Special Top Project (202340110). These funding sources played no part in the study design and will not be involved in data execution, analyzes, or interpretation.