UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Acronym	Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Scientific Title	Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Scientific Title:Acronym	Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Region	Japan

Condition
Condition	colon cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine whether perioperative administration of TJ-100 affects postoperative recovery of gastrointestinal function in patients undergoing surgery for colon cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the time until first flatus following colon surgery
Key secondary outcomes	1.The time until first defecation following colon surgery 2.CRP, WBC, neutrophil of POD 1,3 3.The maximumu of body temperature 4.Hospital stay after colorectal surgery 5.Postoperative complication 6.Adverse events

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	oral administration of TJ-100(15g/day) in perioperative surgery
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with curative resection for colon cancer including cancer of the rectosigmoid that had been diagnosed pre-operatively 2.Patients with a performance status of 0 or 1 3.Patients able to tolerate oral administration of TJ-100 4.Patients aged 20 years or older 5.Patients able to provide written informed consent
Key exclusion criteria	1.Patients taking other Kampo medicines 2.Patients were pregnant, possibly pregnant or considering pregnancy 3.Patients with serious ischemic heart disease 4.Patients with cirrhosis or active hepatitis 5.Patients with dyspnea requiring oxygen administration 6.Patients under dialysis due to chronic renal failure 7.Patients requiring combined resection of any other organ 8.Patients ineligible for the study for any other reason, as judged by the investigator
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Ichiro Middle name Last name Takemasa
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	060-8543
Address	Sapporo, Hokkaido 060-8543, Japan
TEL	011-611-2111
Email	itakemasa@sapmed.ac.jp

Public contact
1st name of contact person	1st name Toshihiko Middle name Last name Nishidate
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	060-8543
Address	Sapporo, Hokkaido 060-8543, Japan
TEL	011-611-2111
Homepage URL
Email	nisidate@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	Sapporo Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Sapporo Medical University
Address	Sapporo, Hokkaido 060-8543, Japan
Tel	011-611-2111
Email	rskk@sapmed.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	2018 Year 05 Month 24 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	Completed
Date of protocol fixation	2017 Year 12 Month 14 Day
Date of IRB	2017 Year 12 Month 15 Day
Anticipated trial start date	2018 Year 01 Month 18 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 24 Day
Last modified on	2019 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037165