UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer
Title of the study (Brief title)	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	Fujii Tsutomu
Organization	Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name	Department of Surgery and Science
Address	2630, Sugitani, Toyama
TEL	076-434-7331
Email	surgery2@med.u-toyama.ac.jp

Public contact
Name of contact person	Baba Hayato
Organization	Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name	Department of Surgery and Science
Address	2630, Sugitani, Toyama
TEL	076-434-7331
Homepage URL
Email	hayato.bb@gmail.com

Sponsor
Institute	University of Toyama
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039464