Prospective observational study to evaluate Lemborexant Utility in iNsomniA women with bReast cancer(WJOG14921B)

Not Applicable

Recruiting

• Conditions: Patients with insomnia who (will or) are receiving hormonal therapy for resectable or metastatic breast cancer

• Registration Number: JPRN-UMIN000047718
• Lead Sponsor: West Japan Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-11
• Last Update Posted: 17 October 2023
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

1) Severe hepatic dysfunction 2) Has a history of administration of LEM (perioperative temporal administration is allowed). 3) Psychiatric disorders that may affect the result of the tests planned in the protocol. 4) Diagnosed as obstructive sleep apnea and receiving Continuous Positive Airway Pressure (CPAP) therapy or narcolepsy 5) Diagnosed as Restless Legs Syndrome (RLS) 6) Diagnosed as dementia 7) Currently receiving or planned to receive cytotoxic anticancer agents or immune checkpoint inhibitors 8) Pregnant, lactating, possibly currently pregnant, or unwilling to use contraception 9) Patient who diagnosed to be inappropriate to the enrollment of this study by the principal investigator/associate investigator

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of mean ISI score at one month in patients who received Lemborexant more than 14 days (Adjuvant hormonal therapy cohort)

Secondary Outcome Measures

Name	Time	Method
1. Percentage of patients with an ISI score of 9 or less (cutoff value for clinical insomnia) 2. Amount of change in ISI score (after 2 weeks and 3 months of taking LEM) 3. Amount of change in ISI sub-items (Items 4-7) 4. Change in the following ISI scores Patients with baseline ISI score less than 15 Patients with a baseline ISI score of 15 or higher 5. Change in total sleep time 6. Change in sleep efficiency 7. Change in fatigue score using the Cancer Fatigue Scale (CFS) 8. Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionare Core 30 (EORTC QLQ C-30) and The European Organization for Research and Treatment of Cancer Quality of Life Questionare-Breast-23 (EORTC QLQ-BR-23). 9. Change in depression score using the Patient Health Questionnaire-9 (PHQ-9) 10. Safety and tolerability