UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047718
Receipt No. R000054408
Scientific Title Prospective observational study to evaluate Lemborexant Utility in iNsomniA women with bReast cancer(WJOG14921B)
Date of disclosure of the study information 2022/05/11
Last modified on 2022/05/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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.