Phase II study of Ninjin'yoeito for anorexia in patients with advanced non-small-cell lung cancer

JRCT ID: jRCTs041220102

Registered date:09/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced non-small-cell lung cancer
• Date of first enrollment: 08/02/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Ninjin'yoeito prescription

Outcome(s)

• Primary Outcome: Change in anorexia score (SNAQ score)
• Secondary Outcome: Changes in weight, BMI, fatigue scale, depression/anxiety scale, safety, and compliance.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age >= 18-year-old
2) Anorexia (SNAQ score >=14 points)
3) ECOG-PS 0-2
4) Expected survival time>= 12 weeks
5) Written informed consent
6) Advanced non-small-cell lung cancer in stage Ill/IV
7) Meets the following test results
1. Hb >= 8.0 g/dl
2. T-Bil <= 2.0 mg/dl
3. AST, ALT<= 150 IU/L
4. Cre <= 3.0 mg/dl
5. Sp02 >=90% or Pa02 >= 60 Torr

Exclude criteria

(1) Receiving cytotoxic chemotherapy within two weeks
(2) Planning to start cytotoxic chemotherapy during the study period
(3) Unable to eat or drink food or take medicines
(4) Treatable causes of anorexia, including electrode abnormalities, peptic ulcer, severe constipation, intracranial disease, psychosis, etc.

Related Information

• Primary Sponsor: Naito Tateaki
• Source(s) of Monetary Support: Kracie Pharma, Ltd.