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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008434
Receipt No. 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

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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
Email 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
Email jscan@jeff.co.jp

Sponsor
Institute Nagoya City University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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