UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective observational study of the impact of chemotherapy on sleep and nutritional status of advanced non-small cell lung cancer
Title of the study (Brief title)	A prospective study of the association between chemotherapy for advanced non-small cell lung cancer and sleep status
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of immune checkpoint inhibitors on sleep status
Basic objectives2	Others
Basic objectives -Others	To investigate the impact of immune checkpoint inhibitors on nutritional status
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The difference of objective sleep time measured by Actiwatch between before and 9 weeks after the initiation of immune checkpoint inhibitors
Key secondary outcomes	The difference of incdence of sleep disturbance between before and 9 weeks after the initiation of immune checkpoint inhibitors The difference of nutritional status between before and 9 weeks after the initiation of immune checkpoint inhibitors Efficacy of each agents (response rate, disease control rate, progression-free survival, overall survival) Any adverse events of each agents The association between the efficacy of immune checkpoint inhibitors and objective physical activity measured by Actiwatch or ECOG-PS

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically diagnosed as non-small cell lung cancer Clinical stage 3b, 3c, 4a or 4b (classified by using 8th edition of UICC TNM classification) An ECOG-PS score of 0 to 2 Scheduled to be treated with immune checkpoint inhibitors Being able to obtain written informed consent
Key exclusion criteria	Severe renal dysfunction (eGFR under 30 ml/min/1.73m2) Severe liver dysfunction (AST or ALT over 100 IU/ml, or T-Bil over 3 mg/dl) Being unable to obtain written informed consent Being unable to obtain sufficient data about primary and secondary outcome
Target sample size	56

Research contact person
Name of lead principal investigator	Osamu Kanai
Organization	National Hospital Organization Kyoto Medical Center
Division name	Division of Respiratory Maedicine
Address	1- 1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
TEL	075-641-9161
Email	geminus75@gmail.com

Public contact
Name of contact person	Osamu Kanai
Organization	National Hospital Organization Kyoto Medical Center
Division name	Division of Respiratory Maedicine
Address	1- 1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
TEL	075-641-9161
Homepage URL
Email	geminus75@gmail.com

Sponsor
Institute	Division of Respiratory Maedicine, National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	Fiduciary funds of National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2018 Year 11 Month 11 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 21 Day
Anticipated trial start date	2018 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	No particular data

Management information
Registered date	2018 Year 11 Month 11 Day
Last modified on	2018 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039739