Efficacy of acupuncture treatment for breast cancer-related insomnia: study protocol for a multicenter randomized controlled trial

• DOI: 10.3389/fpsyt.2024.1301338
• Publication Date: 2024-05-23T04:28:31Z
• Authors: Ping Yin; Qian Fan; Lumin Liu; Ming Yang; Shunxian Zhang; Xu Li; Wenguang Hou; Qifan Feng; Xi Wang; Zhu Jin; Fang Li; Yuelai Chen
• Keywords: Psychiatry; 03 medical and health sciences; breast cancer; 0302 clinical medicine; insomnia; randomized controlled trial; RC435-571; protocol; acupuncture

Background Insomnia is one of the most common symptoms among breast cancer patients, which can be present throughout all stages cancer. As a non-pharmacological alternative treatment, acupuncture has been suggested to improve sleep situations in patients with suffering from insomnia. However, there lack well-designed, high-quality clinical evidence regarding efficacy treatment cancer-related This study conducted evaluate and safety for Methods was designed as multicenter, randomized, sham-controlled trial. A total 264 eligible insomnia will randomized into an group sham 1:1 ratio. In trial, groups receive 12 sessions over consecutive 4-week period. The primary outcome response rate Severity Index (ISI) at week 4; secondary outcomes include remission ISI, Sleep Efficiency (SE) obtained by use diary, ISI 8th 16th weeks follow-up, mean changes Generalized Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Quality Life Questionnaire - Core 30 (QLQ-C30), parameters recorded Actigraphy weekly usage remedial drugs. Adverse events study. All analyses based on ITT principle performed SAS 9.4 statistical software. Discussion trial If proven effective, provide effective option insomnia, play positive role helping reduce their sleeping medications. Clinical registration ClinicalTrials.gov, identifier NCT05510700.