Unique ID issued by UMIN | UMIN000034860 |
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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 |
A prospective observational study of the impact of chemotherapy on sleep and nutritional status of advanced non-small cell lung cancer
A prospective study of the association between chemotherapy for advanced non-small cell lung cancer and sleep status
A prospective observational study of the impact of chemotherapy on sleep and nutritional status of advanced non-small cell lung cancer
A prospective study of the association between chemotherapy for advanced non-small cell lung cancer and sleep status
Japan |
Non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To investigate the impact of immune checkpoint inhibitors on sleep status
Others
To investigate the impact of immune checkpoint inhibitors on nutritional status
Exploratory
Explanatory
Not applicable
The difference of objective sleep time measured by Actiwatch between before and 9 weeks after the initiation of immune checkpoint inhibitors
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
Observational
18 | years-old | <= |
Not applicable |
Male and Female
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
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
56
1st name | |
Middle name | |
Last name | Osamu Kanai |
National Hospital Organization Kyoto Medical Center
Division of Respiratory Maedicine
1- 1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
075-641-9161
geminus75@gmail.com
1st name | |
Middle name | |
Last name | Osamu Kanai |
National Hospital Organization Kyoto Medical Center
Division of Respiratory Maedicine
1- 1 Fukakusa-Mukaihara-Cho, Fushimi-Ku, Kyoto, Japan
075-641-9161
geminus75@gmail.com
Division of Respiratory Maedicine, National Hospital Organization Kyoto Medical Center
Fiduciary funds of National Hospital Organization
Other
NO
2018 | Year | 11 | Month | 11 | Day |
Unpublished
Open public recruiting
2018 | Year | 06 | Month | 21 | Day |
2018 | Year | 11 | Month | 11 | Day |
No particular data
2018 | Year | 11 | Month | 11 | Day |
2018 | Year | 11 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039739
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