Acupuncture for Insomnia in Patients with Breast Cancer: A Single- Center, Single-Blind, Randomized, Controlled Trial Protocol

Abstract

Background and Purpose: Patients with breast cancer have a higher insomnia prevalence than those with other cancers. Acupuncture has fewer side effects than sleep medication and is a good option for patients with breast cancer experiencing insomnia. However, no established principle or guideline exists for patients with breast cancer who use multiple medicines. 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.

Materials and methods: This study is a single-center, single-blind, randomized, 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 and a 3-month follow-up. The primary outcome is the Pittsburgh Sleep Scale (PSQI) total score measured every two weeks. Secondary outcomes include the Generalized Anxiety Disorder (GAD-7) and Patient Health Questionnaire (PHQ9) to assess emotional health and quality of life. We will record the names and dosages of drugs administered for severe insomnia and measure serum 5- hydroxytryptamine(5-HT) concentrations at baseline and 4 and 8 weeks. We will also assess adverse events in details and conduct intention-to-treat analyses using a global statistical test

Conclusion: The study will provide important results to help determine whether acupuncture can become a novel therapy for insomnia in patients with breast cancer.