Unique ID issued by UMIN | UMIN000047718 |
---|---|
Receipt number | 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 | 2022/09/02 10:06:56 |
Prospective observational study to evaluate Lemborexant Utility in iNsomniA women with bReast cancer(WJOG14921B)
LUNAR
Prospective observational study to evaluate Lemborexant Utility in iNsomniA women with bReast cancer(WJOG14921B)
LUNAR
Japan |
Patients with insomnia who (will or) are receiving hormonal therapy for resectable or metastatic breast cancer
Breast surgery |
Malignancy
NO
To evaluate the degree of improvement of insomnia at 1 month after the initiation of Lemborexant treatment
Others
NA
Improvement of mean ISI score at one month in patients who received Lemborexant more than 14 days (Adjuvant hormonal therapy cohort)
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
Observational
20 | years-old | <= |
Not applicable |
Female
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.)
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
70
1st name | Yukinori |
Middle name | |
Last name | Ozaki |
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Department of Breast Medical Oncology
135-8550
3-8-31 Ariake, Kotou-ku, Tokyo, Japan.
03-3520-0111
yukinori.ozaki@jfcr.or.jp
1st name | Shinichiro |
Middle name | |
Last name | Nakamura |
West Japan Oncology Group
WJOG datacenter
556-0016
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, Japan.
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
Eisai Co., Ltd.
Profit organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, IRB committee
3-8-31 Ariake, Kotou-ku, Tokyo, Japan.
03-3520-0111
med.shinsa@jfcr.or.jp
NO
2022 | Year | 05 | Month | 11 | Day |
Unpublished
Open public recruiting
2022 | Year | 04 | Month | 30 | Day |
2022 | Year | 07 | Month | 22 | Day |
2022 | Year | 09 | Month | 01 | Day |
2024 | Year | 12 | Month | 01 | Day |
2025 | Year | 09 | Month | 01 | Day |
To evaluate the association between insomnia severity, estrogen, orexin A levels, and other factors in breast cancer patients.
2022 | Year | 05 | Month | 11 | Day |
2022 | Year | 09 | Month | 02 | Day |
Value
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 |