UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006941 |
|---|---|
| Receipt number | R000008184 |
| Scientific Title | A study to evaluate the efficacy of EPA enriched oral nutrition supplement (ONS) and to investigate useful biomarkers for the assessment in advanced gastrointestinal cancer patients |
| Date of disclosure of the study information | 2011/12/26 |
| Last modified on | 2014/08/18 13:23:04 |
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Basic information
Public title
A study to evaluate the efficacy of EPA enriched oral nutrition supplement (ONS) and to investigate useful biomarkers for the assessment in advanced gastrointestinal cancer patients
Acronym
A study to evaluate the efficacy of EPA enriched oral nutrition supplement (ONS) and to investigate useful biomarkers for the assessment in advanced gastrointestinal cancer patients
Scientific Title
A study to evaluate the efficacy of EPA enriched oral nutrition supplement (ONS) and to investigate useful biomarkers for the assessment in advanced gastrointestinal cancer patients
Scientific Title:Acronym
A study to evaluate the efficacy of EPA enriched oral nutrition supplement (ONS) and to investigate useful biomarkers for the assessment in advanced gastrointestinal cancer patients
Region
| Japan |
Condition
Condition
Gastric cancer/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 efficacy of EPA on nutrition status and quality of life (QOL), and to investigate useful markers for the efficacy of EPA in advanced gastrointestinal cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
QOL (QOL-ACD) at before and 14days,28days after the administration of EPA
Key secondary outcomes
At before and 14days,28days after the administration of EPA
1) Nutrition status
2) Glasgow Prognostic Score (GPS)
3) The expression of cytokines
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
| Food |
Interventions/Control_1
2 packs of an EPA enriched oral nutrition supplement (ONS) per day for 14 days
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. GPS:1 or 2
2. Oral intake
3. No abnormality in digestive organs due to endogenous diseases
4. Patients who undergo chemotherapy or who are scheduled to undergo chemotherapy
5. Life expectancy more than 3 months
6. No serious complications
Key exclusion criteria
1. Metastatic brain disorder
2. Immune disorder
3. Cardiac disease, liver failure, renal failure, and active disease of small intestine (e.g., Crohn's disease)
4. Gastrointestinal symptoms (e.g., Intestinal obstruction, gastrointestinal bleeding, etc)
5. Allergic to the ingredient (s)
6. Uncontrollable diabetes mellitus
7. Considered inadequate for the inclusion in the study by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouki Kuwabara |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive Tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama, Japan
TEL
049-228-3619
47kkuwa@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouki Kuwabara |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive Tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama, Japan
TEL
049-228-3619
Homepage URL
47kkuwa@saitama-med.ac.jp
Sponsor or person
Institute
Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
埼玉医科大学総合医療センター(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 26 | 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
| 2011 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | 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
| 2011 | Year | 12 | Month | 24 | Day |
Last modified on
| 2014 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008184
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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