The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma

JRCT ID: jRCTs021210048

Registered date:18/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced urothelial carcinoma, Sarcopenia
• Date of first enrollment: 18/11/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Priscribe Ninjin'yoeito 5-7.5 g/day orally for patients with advanced urothelial carcinoma who recieve platinum-based chemotherapy during 2 months

Outcome(s)

• Primary Outcome: To compare the change rates of psoas muscle area of study participants with those of historical cohort 8 weeks after the study commencement
• Secondary Outcome: The evaluation of change in frailty, body composition, and serum grelin levels 4 and 8 weeks after the study.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Patients with advanced urothelial carcinoma who recieve platinum-based chemotherapy (Age; 65-90 years)
2. Patients who understand and are willing to participate this study.
3. Patients without a severe general condition due to progressive disease.
4. Patients without an abnormality in liver function and serum potassium level.
5. Patients who do not take other harbal medicines which have supportive roles for cancer treatment.

Exclude criteria

1. Patients can not take a harbal medicine due to dysphagia and/or tube feeding.
2. Patients who have already took other harbal medicines which have supportive roles for cancer treatment.

Related Information

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