Acupuncture for insomnia in patients with breast cancer: a single-center, single-blind, randomised, controlled trial protocol

Abstract

Abstract Background Patients with breast cancer have a high incidence of insomnia, which is often accompanied by anxiety, depression, and fatigue. Acupuncture is considered useful for insomnia and emotional disorders and is becoming increasingly acceptable for patients with cancer. However, few studies have been conducted on acupuncture for patients with breast cancer who are suffering from insomnia. This study aims to describe a protocol for an 8-week acupuncture intervention to explore the efficacy and safety of acupuncture therapy using the “regulating spirit and soothing liver” method for treating insomnia patients with breast cancer. Methods This study is a single-center, single-blind, randomised, controlled trial. We aim to recruit 70 females, aged 18-60 years, who will be randomly allocated to the intervention (acupuncture) or control (sham acupuncture) groups. The intervention will include an 8-week acupuncture therapy followed by a 3-month follow-up period. The primary outcome is the Pittsburgh Sleep Scale(PSQI) measured every two weeks. Secondary outcomes are the Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire (PHQ9), and Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) to assess emotional health and quality of life. We will also record the drug name and quantity given to treat severe insomnia. We also will measure serum 5-hydroxytryptamine(5-HT) concentrations at baseline and again at 4 and 8 weeks. Adverse events will be recorded in detail throughout the trial. Intention-to -treat analyses will be conducted, and the data will be assessed using a global statistical test. Ethical approval for this trial was granted by the Institutional Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine, Capital Medical University(2022BL02-059-02). Written informed consent was obtained from enrolled patients and will last throughout the trial. The trial results will be disseminated through peer-reviewed publications and conferences. Discussion Patients with breast cancer are more likely to experience insomnia, and it may influence the curative effect of their treatments. Undoubtedly, more attention is needed regarding insomnia in these patients; however, there is no established principle or guideline for patients with breast cancer who take multiple different medicines. Therefore, acupuncture may be useful as a less harmful intervention. Trial registration number ISRCTN12913513, 7 March,2023