UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031984 |
|---|---|
| Receipt number | 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 18:23:52 |
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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
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
thagiwa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university Department of Coloproctological Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036382
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
