UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034860 |
|---|---|
| Receipt number | R000039739 |
| Scientific Title | A prospective observational study of the impact of chemotherapy on sleep and nutritional status of advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2018/11/11 |
| Last modified on | 2018/11/11 22:44:41 |
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Basic information
Public title
A prospective observational study of the impact of chemotherapy on sleep and nutritional status of advanced non-small cell lung cancer
Acronym
A prospective study of the association between chemotherapy for advanced non-small cell lung cancer and sleep status
Scientific Title
A prospective observational study of the impact of chemotherapy on sleep and nutritional status of advanced non-small cell lung cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Osamu Kanai |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Respiratory Maedicine
Zip code
Address
1- 1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
TEL
075-641-9161
geminus75@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Kanai |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Respiratory Maedicine
Zip code
Address
1- 1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
geminus75@gmail.com
Sponsor or person
Institute
Division of Respiratory Maedicine, National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2018 | Year | 06 | Month | 21 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039739
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| Registered date | File name |
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| Registered date | File name |
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