UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031984
Receipt No. R000036382
Scientific Title Safety and usefulness of preoperative administration of oral nutrient containing arginine, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) in patients with colon cancer surgery
Date of disclosure of the study information 2018/03/30
Last modified on 2018/03/29

* 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 Safety and usefulness of preoperative administration of oral nutrient containing arginine, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) in patients with colon cancer surgery
Acronym Safety and usefulness of preoperative administration of oral nutrient containing arginine, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) in patients with colon cancer surgery
Scientific Title Safety and usefulness of preoperative administration of oral nutrient containing arginine, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) in patients with colon cancer surgery
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuhiro Sakamoto
Organization Juntendo university
Division name Department of Coloproctological Surgery
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kazusaka@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Hagiwara
Organization Juntendo university
Division name Department of Coloproctological Surgery
Zip code
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)

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 03 Month 30 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 02 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.