UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004899 |
|---|---|
| Receipt number | R000005835 |
| Scientific Title | Evaluation of Usefulness and Safety of Support Food for Recovery of Eating Function iEat in Patients with Gastrointestinal Cancer Stenosis. |
| Date of disclosure of the study information | 2011/01/19 |
| Last modified on | 2014/12/01 14:13:35 |
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Basic information
Public title
Evaluation of Usefulness and Safety of Support Food for Recovery of Eating Function iEat in Patients with Gastrointestinal Cancer Stenosis.
Acronym
Evaluation of Usefulness and Safety of Support Food for Recovery of Eating Function iEat in Patients with Gastrointestinal Cancer Stenosis.
Scientific Title
Evaluation of Usefulness and Safety of Support Food for Recovery of Eating Function iEat in Patients with Gastrointestinal Cancer Stenosis.
Scientific Title:Acronym
Evaluation of Usefulness and Safety of Support Food for Recovery of Eating Function iEat in Patients with Gastrointestinal Cancer Stenosis.
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether iEat is safety in patients for whom gastrointestinal cancer stenosis is indicated. Furthermore, to evaluate satisfaction of iEat compare to the regular hospital diet by feeding rate and questionnaire.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate safety (digestive symptoms) during the trial (in principal 7 days). Outcomes are abdominal pain, diarrhea, abdominal fullness, nausea, vomiting. Outcomes will be graded according to Common Terminology Criteria for Adverse Events v.4.0 JCOG version (Abbr. CTCAE v4.0 JCOG) [Equiv. CTCAE v4.02/MedRA/J v12.1 Published February 1, 2010]
Key secondary outcomes
Feeding rate
Questionnaire about satisfaction
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
Study period will be seven consecutive days. Five consecutive days of iEat and before-and-after one day of regular diet. iEat will be provided only lunch every day. Breakfast and dinner will be regular hospital diet (rice porridge or liquid diet).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have given voluntary written informed consent
2)Patients aged 20 years and older at the time of informed consent
3)Male or female patients
4)Do not consider presence or absence of gastrointestinal stent placement
5)Do not consider presence or absence of chemotherapy
Key exclusion criteria
1)Patients who cannot be communicated with the investigator, etc. due to disturbance of consciousness and dementia, etc.
2)Patients with food allergy
3)Patients with concomitantly-used tube feeding
4)Patients judged to be inappropriate for the study by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | IIJIMA, Shohei |
Organization
Minoh City Hospital
Division name
Department of Surgery
Zip code
Address
5-7-1, Kayano, Minoh, Osaka 562-8562, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Minoh City Hospital
Division name
Department of Surgery
Zip code
Address
5-7-1, Kayano, Minoo, Osaka 562-8562, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Minoh City Hospital
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2011 | Year | 01 | Month | 19 | 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
| 2010 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 19 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005835
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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