Prospective observational study to evaluate lemborexant utility in insomnia among women with breast cancer (WJOG14921B, LUNAR study).

Abstract

TPS12148 Background: Insomnia occurs in approximately 60% of cancer patients. The importance of early intervention to treat insomnia has been advocated because insomnia may be associated with poor prognosis, early discontinuation of treatment and decreased quality of life. It has been reported that breast cancer patients receiving endocrine therapy have the highest rate of insomnia among all cancer patients due to vasomotor symptoms (ie, hot flashes) and comorbid symptoms associated with fatigue and depression. Insomnia has also been found to occur in patients with metastatic/recurrent breast cancer. Lemborexant (LEM) is a dual orexin receptor antagonist, which has been shown to be effective for insomnia patients without malignancies. In clinical practice, while LEM has been administered to cancer patients with insomnia, there are no prospective data. The aim of this study is to evaluate prospectively whether LEM improves insomnia in patients with breast cancer receiving endocrine therapy. Methods: This is an open-label, prospective, multicenter, observational study to evaluate efficacy and safety of LEM to treat insomnia in patients with breast cancer receiving endocrine therapy [UMIN000047718]. The primary endpoint is change from baseline of total Insomnia Severity Index (ISI) score at 1 month. Secondary endpoints include change from baseline of cancer fatigue scale scores, EORTC QLQ C-30 and BR23 score, and Patient Health Questionnaire-9 score after 1 month and 3 months, change from baseline in total sleep time and sleep efficiency using an electronic sleep diary after 2 weeks, 1 month and 3 months, and safety profile. Exploratory endpoints include biomarker analysis including evaluation of cytokines and orexin A levels, and evaluation of sleep parameters using Oura ring, which is a ring-type wearable device. The primary endpoint will be assessed by the Wilcoxon signed-rank test. Total sample size will be 70 patients (adjuvant cohort: 50 patients, recurrent and/or metastatic cohort: 20 patients). Patients ≥20, meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for Insomnia Disorder and ISI score ≥10 will be eligible. LEM 5mg will be administrated orally every night. Dosage of LEM will follow clinical practice and the Japanese LEM label. Enrollment began in September 2022; 14 patients have been recruited in adjuvant cohort as of January 2023. Clinical trial information: UMIN000047718 .