Efficacy of oral Ninjin'yoeito for improvement of fatigability and nutritional status in the perioperative period of primary lung cancer

Not Applicable

Recruiting

• Conditions: Primary lung cancer; primary lung cance, non-small cell lung cancer, small cell lung cancer; D002289, D055752

• Registration Number: JPRN-jRCT1031210136
• Lead Sponsor: Ishibashi Hironori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

1. Patients aged 65 years or older who will undergo anatomical lung resection and systematic lymph node dissection for primary lung cancer at our department.
2. Patients who have given written consent for this study.
3. Patients with primary lung cancer in stages 0, I, II and III.

Exclusion Criteria

1. The patient does not give consent to participate in the study.
2.The patient has a history of allergy to Ninjin'yoeito or its components.
3. The patient has severe anorexia, nausea, or vomiting, which is a cautious administration of the study drug.
4. The patient with severe hepatic or renal dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chalder Fatigue Scale before administration of Ninjin'yoeito, a month after surgery, and 6 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Cancer Fatigue Scale, Kihon Checklist (KCL), and Controlling nutrition status (COUNT)and Prognostic nutritional index(PNI) before administration of Ninjin'yoeito, a month after surgery, and 6 months after surgery.