UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044092
Receipt number R000050352
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)
Date of disclosure of the study information 2021/06/01
Last modified on 2021/05/01 16:25:42

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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 or person

Institute

Hirosaki University hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050352


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name