UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034613
Receipt number R000039464
Scientific Title The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer
Date of disclosure of the study information 2018/11/15
Last modified on 2018/10/24 00:59:55

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer

Acronym

The Exploratory Study about Efficacy and Safety of Ninjin'yoeito in Postoperative Patients with Colorectal Cancer

Scientific Title

The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer

Scientific Title:Acronym

The Exploratory Study about Efficacy and Safety of Ninjin'yoeito in Postoperative Patients with Colorectal Cancer

Region

Japan


Condition

Condition

Colorectal Cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy and safety of Ninjin'yoeito for fatigue and malaise expressed in postoperative elderly patients with colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fatigue and Malaise: The Evaluation by Chaludder fatigue questionnaire

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The administration of Ninjin'yoeito

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

80 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with resected colorectal cancer (clinical stage I to IIIb)
2) Patients with Grade 1 or higherfatigue or malaise after surgery (CTCAE ver. 4.0)
3) Patients with ECOG PS 0 to 2
4) Patients whose main organ functions are adequately maintained
5) Age: over 80 years old (when acquiring consent)
6) Category of examination: Outpatient and hospitalization
7) Patients who can be orally administered
8) Patients who wrote consent form to participate in this study

Key exclusion criteria

1) Patients with active other cancers
2) Patients with severe complications (such as liver disease, renal disease, heart disease, blood disease or metabolic disease) or mental disease
3) Patients taking drugs banned in this study or Ninjin'yoeito within 4 weeks before the start of the study
4) Patients who have a history of allergies to traditional Chinese medicine

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fujii Tsutomu

Organization

Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama

Division name

Department of Surgery and Science

Zip code


Address

2630, Sugitani, Toyama

TEL

076-434-7331

Email

surgery2@med.u-toyama.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Baba Hayato

Organization

Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama

Division name

Department of Surgery and Science

Zip code


Address

2630, Sugitani, Toyama

TEL

076-434-7331

Homepage URL


Email

hayato.bb@gmail.com


Sponsor or person

Institute

University of Toyama

Institute

Department

Personal name



Funding Source

Organization

University of Toyama

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 11 Month 15 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

2018 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 24 Day

Last modified on

2018 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039464


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name