A prospective observational study of the impact of chemotherapy on sleep and nutritional status of advanced non-small cell lung cancer

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034860

Enrollment

Registered

2018-11-11

Start date

2018-11-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The difference of objective sleep time measured by Actiwatch between before and 9 weeks after the initiation of immune checkpoint inhibitors	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactOsamu Kanai

National Hospital Organization Kyoto Medical Center Division of Respiratory Maedicine

geminus75@gmail.com075-641-9161

Outcome results