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Efficacy and mechanism of long-snake moxibustion for treating insomnia in breast cancer survivors: study protocol for a randomized controlled trial

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机构: [1]Chengdu Univ Tradit Chinese Med, Sch Clin Med, Chengdu, Peoples R China [2]Hosp Chengdu Univ Tradit Chinese Med, Dept Oncol, Chengdu, Peoples R China [3]Hosp Chengdu Univ Tradit Chinese Med, Hlth Management Ctr, Chengdu, Peoples R China [4]Univ Elect Sci & Technol China, Dept Radiat Oncol,Affiliated Canc Hosp, Radiat Oncol Key Lab Sichuan Prov,Sichuan Canc Ctr, Sichuan Clin Res Ctr Canc,Sichuan Canc Hosp & Inst, Chengdu, Peoples R China
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关键词: randomized controlled trial protocol moxibustion insomnia breast cancer survivors

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Background Insomnia (difficulty falling or staying asleep) is a common issue among breast cancer survivors, significantly impacting their quality of life. Current treatments, primarily pharmacological and psychological, have limitations: the former often causes side effects, while the latter faces accessibility barriers. Long-snake moxibustion (LSM), a traditional Chinese medicine (TCM) technique, involves applying moxibustion along the governor vessel, which is an important meridian in TCM that plays a key role in regulating brain function. LSM is characterized by its minimal side effects, ease of application, and cost-effectiveness, with preliminary studies supporting its potential for treating insomnia. This study aims to further investigate the therapeutic effectiveness of LSM in alleviating insomnia among breast cancer survivors and to explore its underlying mechanisms. Methods This single-center, rater-masked, randomized controlled trial will enroll 100 breast cancer survivors with chronic insomnia, who will be randomly assigned in a 1:1 ratio to either the LSM group or a waitlist control group. During the 4-week treatment period, all participants will receive standard care, with the LSM group additionally receiving LSM treatment twice a week. The primary efficacy outcome is the change in Insomnia Severity Index (ISI) score at the end of the intervention. Secondary outcomes include changes in hypnotic medication use, Pittsburgh Sleep Quality Index (PSQI) scores, Piper Fatigue Scale (PFS) scores, and Functional Assessment of Cancer Therapy-Breast (FACT-B) scores. Mechanistic evaluations will assess serum biochemical markers, gut microbiota composition, and metabolomic profiles. Discussion If proven effective, this trial will provide critical clinical evidence supporting LSM as a viable and accessible treatment for insomnia among breast cancer survivors. The findings could influence clinical practice by offering a non-pharmacological treatment option, improving patient outcomes, and reducing dependence on pharmacological interventions. Furthermore, exploring the underlying mechanisms may enhance our understanding of how LSM works, paving the way for future research. Clinical trial registration http://itmctr.ccebtcm.org.cn/, identifier ITMCTR2024000578.

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大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学
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大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学
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Q2 CLINICAL NEUROLOGY Q3 NEUROSCIENCES
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Q2 CLINICAL NEUROLOGY Q3 NEUROSCIENCES

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第一作者机构: [1]Chengdu Univ Tradit Chinese Med, Sch Clin Med, Chengdu, Peoples R China
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