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Auricular acupuncture for insomnia in female patients with non-metastatic breast cancer: study protocol for a
Lumin Liu1, Shihan Jiang1, Meina Ye2
1Sleep Medicine Centre, LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Background:
Breast cancer patients are at an increased risk of insomnia, which can lead to emotional disorders, reduced quality of life, and potentially higher cancer mortality. Auricular acupuncture (AA) offers a feasible treatment option due to its short procedure time, low technical complexity, and relative safety. However, while preliminary studies suggest potential benefits of AA for treating insomnia, the evidence for the population of breast cancer patients remains insufficient.
Methods:
This study employs a multicenter single-blind, randomized, controlled trial. A total of 324 patients will be randomly assigned in a 1:1 ratio to either the AA group (n=162) or the nonspecific AA group (NAA) (n=162). Both groups will undergo a 4-week treatment period, with three daily sessions. Follow-up assessments will be conducted at weeks 8 and 16. The primary outcome is the treatment response rate at week 4, and secondary outcomes include the treatment remission rate, the treatment response rate at weeks 8 and 16, change in Insomnia Severity Index (ISI) score, sleep diary, Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Quality of Life Questionnaire-Core 30 (QLQ-C30), and emergency medication usage. Data will be collected at baseline (week 0), during the intervention (week 2), post-treatment (week 4), and at follow-up (weeks 8 and 16).
Discussion:
This study represents an initial effort to develop a comprehensive standard operating procedure (SOP) that includes graphic and video instructions for auricular point location and manipulation techniques. It also provides online guidance to instruct patients on how to self-administer AA at home. The aim of the study is to evaluate the clinical efficacy and safety of AA in treating insomnia among female patients with non-metastatic breast cancer. The findings will provide new insights into the promotion of AA for managing breast cancer-related insomnia in a home-use setting, a method that has the potential to conserve medical resources and alleviate economic burdens.
Trial Registration:
https://itmctr.ccebtcm.org.cn/mgt/project/view/-7546531521559384755, identifier ITMCTR2025001101.
