A prospective observational study of the impact of chemotherapy on sleep and nutritional status of advanced non-small cell lung cancer
Not Applicable
Recruiting
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000034860
- Lead Sponsor
- Division of Respiratory Maedicine, National Hospital Organization Kyoto Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference of objective sleep time measured by Actiwatch between before and 9 weeks after the initiation of immune checkpoint inhibitors
- Secondary Outcome Measures
Name Time Method 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