UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008434 |
|---|---|
| Receipt number | R000009738 |
| Scientific Title | Effect of oral nutrition supplement enriched with eicosapentaenoic acid (Prosure) on inflammatory response following colon cancer surgery: A Phase II randomized controlled study |
| Date of disclosure of the study information | 2012/07/13 |
| Last modified on | 2016/02/18 14:11:19 |
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Basic information
Public title
Effect of oral nutrition supplement enriched with eicosapentaenoic acid (Prosure) on inflammatory response following colon cancer surgery: A Phase II randomized controlled study
Acronym
Effect of oral nutrition supplement enriched with eicosapentaenoic acid (Prosure) on inflammatory response following colon cancer surgery: A Phase II randomized controlled study
Scientific Title
Effect of oral nutrition supplement enriched with eicosapentaenoic acid (Prosure) on inflammatory response following colon cancer surgery: A Phase II randomized controlled study
Scientific Title:Acronym
Effect of oral nutrition supplement enriched with eicosapentaenoic acid (Prosure) on inflammatory response following colon cancer surgery: A Phase II randomized controlled study
Region
| Japan |
Condition
Condition
Colon Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of oral nutrition supplement enriched with eicosapentaenoic acid (Prosure) on inflammatory response following colon cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
IL-6
Key secondary outcomes
CRP
Inflammatory markers (body temperature and WBC)
Adherence
Length of stay
Complication rate
Nutrition Status (prealbumin, weight, and hand grip)
Safety and adverse effects (clinical finding and clinical data)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral supplementation of 2 packs of Prosure per day for 14days before colon cancer surgery
Interventions/Control_2
Prosure is not ingested
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologically proven colon cancer
2.Laparoscopic excision
3.Written informed consent
4.Age ranging between 20 and 79 years old
5.Oral intake
6.CRP>=0.5mg/dL
7.Function of main organs is well preserved
Key exclusion criteria
1.Intestinal obstruction and enterostenosis (unable to take orally)
2.Multiple carcinoma
3.Stage III b<= and T1>=
4.Patient who is going to take abdominoperineal rectal resection
5.Patient who is going to remove other organs
6.Patient who is not going to remove the carcinoma
7.Patient who requires blood transfusion
8.BMI>=30kg/m2
9.Cardiac disease, liver failure, and renal failure
10.Steroid use
11.Antimicrobial use within 2 weeks
12.Allergic tendency
13.Allergic to the ingredients
14.Woman pregnant and /or nursing, or woman who is willing to be pregnant
15.Focus of infection
16.Chronic inflammation
17.ASA score>=3
18.Unable to provide consent
19.Chemotherapy or radiotherapy
20.Uncontrollable DM
21.Hematencephalon or subarachnoidal hemorrhage within a month
22.EPA supplement use
23.Considered inadequate for the inclusion in the study by the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Takeyama |
Organization
Nagoya City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
1, Kawasumi, Mizuho-cho Mizuho-ku, Nagoya Aichi 468-8601 Japan
TEL
052-853-8226
jscan@jeff.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nanami Sato |
Organization
Japanese Society for Cancer Nutrition Therapy
Division name
Secretariat
Zip code
Address
Shibadaimon116Bldg.3F,1-16-3Shiba-Daimon,Minato-ku,Tokyo105-0012,Japan c/o JEFF CORPORATION CO.,LTD.
TEL
03-3578-0303
Homepage URL
jscan@jeff.co.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Cancer Immunonutrition Study Group
Organization
Division
Category of Funding Organization
Self funding
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
東邦大学医療センター大森病院（東京都）
順天堂大学附属静岡病院（静岡県）
国立病院機構名古屋医療センター（愛知県）
株式会社日立製作所 日立総合病院（茨城県）
知多厚生病院（愛知県）
静岡県立総合病院（静岡県）
公立陶生病院（愛知県）
福岡大学（福岡県）
岡山医療センター（岡山県）
京都民医連中央病院（京都府）
順天堂大学附属順天堂医院（東京都）
伊賀市立上野総合市民病院（三重県）
愛媛大学（愛媛県）
前橋赤十字病院（群馬県）
山梨厚生病院（山梨県）
宮城厚生協会坂総合病院（宮城県）
名古屋市立大学（愛知県）
川崎医科大学（岡山県）
仙台医療センター仙台オープン病院（宮城県）
名古屋市立東部医療センター（愛知県）
名古屋徳洲会総合病院（愛知県）
公立藤岡総合病院（群馬県）
中野胃腸病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 13 | 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
| 2012 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 13 | Day |
Last modified on
| 2016 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009738
