UMIN-CTR Clinical Trial

Basic information
Public title	The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma who received systemic chemotherapy (A single-center, single-arm, open-label trial)
Acronym	The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma
Scientific Title	The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma who received systemic chemotherapy (A single-center, single-arm, open-label trial)
Scientific Title:Acronym	The preventive effect of Ninjin'yoeito on sarcopenia among patients with advanced urotherial carcinoma
Region	Japan

Condition
Condition	Advanced urothelial carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Ninjin'yoeito is a herbal medicine that has the potential to improve anorexia and prevent loss of skeletal muscle mass and strength. However, its effect on the prevention of worsening sarcopenia in patients who who receive systemic chemotherapies remains unknown. Therefore, we conduct a pilot study to investigate the effects of Ninjin'yoeito on sarcopenia in patients with advanced urothelial carcinoma who receive systemic chemotherapies.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The evaluation of change in the area of psoas muscle 8 weeks after the study.
Key secondary outcomes	The evaluation of change in frailty, body composition, and serum grelin levels 4 and 8 weeks after the study.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Priscribe Ninjin'yoeito 5-7.5 g/day orally for patients with advanced urothelial carcinoma who recieve platinum-based chemotherapy during 2 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with advanced urothelial carcinoma who recieve platinum-based chemotherapy (Age; 20-90 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.
Key exclusion 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.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Teppei Middle name Last name Okamoto
Organization	Hirosaki University hospital
Division name	Center for Clinical Trial Management
Zip code	036-8562
Address	Zaihu-cho 5 Hirosaki Aomori
TEL	0172335111
Email	t-okamoto@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Teppei Middle name Last name Okamoto
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Urology
Zip code	036-8562
Address	Zaihu-cho 5 Hirosaki Aomori
TEL	0172335111
Homepage URL
Email	t-okamoto@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University hospital
Institute
Department

Funding Source
Organization	Kracie Pharmaceutical, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hirosaki University hospital
Address	Zaihu-cho 5 Hirosaki Aomori
Tel	0172335111
Email	t-okamoto@hirosaki-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2023 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 01 Day
Last modified on	2021 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050352