UMIN-CTR Clinical Trial

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

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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 or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



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

Open public recruiting

Date of protocol fixation

2022 Year 04 Month 30 Day

Date of IRB

2022 Year 07 Month 22 Day

Anticipated trial start date

2022 Year 09 Month 01 Day

Last follow-up date

2024 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2025 Year 09 Month 01 Day


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 09 Month 02 Day



Link to view the page

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