A randomized controlled trial of Ninjin yoeito for lung cancer

JRCT ID: jRCTs051200009

Registered date:01/05/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: lung cancer
• Date of first enrollment: 07/09/2020
• Target sample size: 140
• Study type: Interventional

Intervention(s)

Conventional treatment group: Treated with conventional therapy for 4 months after operation.
NINJIN-YOUEI-TO group: In addition to conventional treatment, Kracie NINJIN-YOUEI-TO Extract Fine Granules (7.5 g / day) is prescribed for 4 months after the operation.

Outcome(s)

• Primary Outcome: CFS (Cancer Fatigue Scale)
• Secondary Outcome: Breathlessness (VAS), Cancer Dyspnea Scale, MD Anderson Symptom Inventory, Basic Check List (Flail Assessment Tool), Spirometry, Effort Force Capacity, 1 Second Amount, 1 Second Rate, Pulmonary Diffusion Ability, Weight, Blood test

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients over 20 years old with performance status of 0-1 who were diagnosed or suspected with primary lung cancer.
2. Patients undergoing uni-lobectomy with group-2 lymphadenectomy.
3. Patients who consented to the study in writing.
4. Patients scheduled to undergo thoracoscopic surgery including robot-assisted surgery.

Exclude criteria

1. Patients who have history of allergies in NINJIN-YOUEI-TO in the past.
2. Patients who were treated with Kampo formulation for this symptom within 2 weeks before the start of this study.
3. Patients who have severe anorexia, nausea and vomiting which are careful administration of this drug.
4. Patients whom the doctor judged unsuitable as the subject.
5. Patients who do not retain liver function and kidney function
-Total Bilirubin <=2.0mg/dL
-Serum creatinine <=2.0mg/dL
6. Patients with conversion to open thoracotomy.
7. Patients with pulmonary resection range of 2 or more lobes.
8. Patients who cannot drink water within 3 days after surgery.

Related Information

• Primary Sponsor: Tanaka Yugo
• Source(s) of Monetary Support: Kracie Pharmaceutical, Ltd.