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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041220102

Registered date:09/12/2022

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAdvanced non-small-cell lung cancer
Date of first enrollment08/02/2023
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)Ninjin'yoeito prescription

Outcome(s)

Primary OutcomeChange in anorexia score (SNAQ score)
Secondary OutcomeChanges in weight, BMI, fatigue scale, depression/anxiety scale, safety, and compliance.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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

Contact

Public contact
Name Tateaki Naito
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail t.naito@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Tateaki Naito
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail t.naito@scchr.jp
Affiliation Shizuoka Cancer Center