UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and usefulness of preoperative administration of oral nutrient containing arginine, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) in patients with colon cancer surgery
Title of the study (Brief title)	Safety and usefulness of preoperative administration of oral nutrient containing arginine, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) in patients with colon cancer surgery
Region	Japan

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

Objectives
Narrative objectives1	It is aimed to evaluate the safety and usefulness of ingesting a nutritient rich in arginine, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Surgical site infection (SSI) such as wound infection and intraperitoneal abscess. Infectious diseases other than SSI such as respiratory infections and urinary tract infections. Incidence of suture failure.
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 Food
Interventions/Control_1	Subjects take a new Investigational new food "Impact" of 125 ml / 1 pack 4 packs a day from 6 days before the scheduled operation date to 2 days before the scheduled operation date.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1. Cases diagnosed as histologically colon cancer. 2. Cases who intestinal resection is scheduled. 3. Cases who can eat by oral ingestion. 4. After receiving sufficient explanation for participation in the research, cases that written consent was obtained.
Key exclusion criteria	1. Cases with intestinal obstruction and high intestinal stenosis. 2. Duplicated cancer cases. 3. Cases with heart dysfunction, liver dysfunction, and kidney dysfunction. 4. Cases who are prescribed prednisolone 6 mg / day cases of steroid. 5. Pregnant women, breast-feeding cases, and cases that may be pregnant. 6. Cases who are observed clear infection foci before registration. 7. Cases after total gastrectomy. 8. Cases with Parkinson's disease; Hoehn and Yahr scale 3 or more. 9. Cases who are prescribed immunosuppressive drugs. 10. Cases with milk allergy and/or soybeans allergy. 11. Case having diabetes with HbA1c 7.0 or higher. 12. Cases considered inappropriate by researchers.
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuhiro Sakamoto
Organization	Juntendo university
Division name	Department of Coloproctological Surgery
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	kazusaka@juntendo.ac.jp

Public contact
Name of contact person	Toshiaki Hagiwara
Organization	Juntendo university
Division name	Department of Coloproctological Surgery
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	thagiwa@juntendo.ac.jp

Sponsor
Institute	Juntendo university Department of Coloproctological Surgery
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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 03 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 02 Day
Anticipated trial start date	2017 Year 03 Month 02 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 03 Month 29 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036382