Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial.

Background: Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients' quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer.

Method: This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%.

Discussion: This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors.

Trial Registration: ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068.