UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study to evaluate Lemborexant Utility in iNsomniA women with bReast cancer(WJOG14921B)
Acronym	LUNAR
Scientific Title	Prospective observational study to evaluate Lemborexant Utility in iNsomniA women with bReast cancer(WJOG14921B)
Scientific Title:Acronym	LUNAR
Region	Japan

Condition
Condition	Patients with insomnia who (will or) are receiving hormonal therapy for resectable or metastatic breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the degree of improvement of insomnia at 1 month after the initiation of Lemborexant treatment
Basic objectives2	Others
Basic objectives -Others	NA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of mean ISI score at one month in patients who received Lemborexant more than 14 days (Adjuvant hormonal therapy cohort)
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) Patient who does not regularly use drug for insomnia at the time of informed consent 2) Patient who will receive LEM 3) Patient meets the diagnostic criteria for insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) 4) ISI score of 10 or higher 5) Patient who can operate a smart phone appropriately and wear a wearable device (Oura ring) during the observation period. 6) Patient must have been fully informed of the study and their written consent must have been obtained prior to enrollment in the study. In addition to the above, selection criteria for each cohort are described below. Cohort 1 1) Diagnosed as stage I-III hormone receptor-positive breast cancer 2) Patient has received treatment (including surgery, preoperative and postoperative chemotherapy, molecular-targeted drugs, and radiation therapy) for primary breast cancer with curative intent , and general health condition is stable at least 2 weeks after surgery. 3) Patient receiving or planned to receive adjuvant hormonal therapy. Cohort 2 1) Diagnosed as stage VI or metastatic hormone receptor-positive breast cancer 2) Patient receiving or planned to receive hormonal therapy alone or with molecular targeted drugs (trastuzumab, pertuzumab, CDK4/6 inhibitor, etc.)
Key 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
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yukinori Middle name Last name Ozaki
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Department of Breast Medical Oncology
Zip code	135-8550
Address	3-8-31 Ariake, Kotou-ku, Tokyo, Japan.
TEL	03-3520-0111
Email	yukinori.ozaki@jfcr.or.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code	556-0016
Address	Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, Japan.
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	Eisai Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research, IRB committee
Address	3-8-31 Ariake, Kotou-ku, Tokyo, Japan.
Tel	03-3520-0111
Email	med.shinsa@jfcr.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2024 Year 09 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To evaluate the association between insomnia severity, estrogen, orexin A levels, and other factors in breast cancer patients.

Management information
Registered date	2022 Year 05 Month 11 Day
Last modified on	2022 Year 05 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054408

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.