UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008338 |
|---|---|
| Receipt number | R000009816 |
| Scientific Title | Efficacy of elemental diet for esophageal cancer chemotherapy |
| Date of disclosure of the study information | 2012/07/11 |
| Last modified on | 2017/01/10 12:13:54 |
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Basic information
Public title
Efficacy of elemental diet for esophageal cancer chemotherapy
Acronym
elemental diet for oral mucositis
Scientific Title
Efficacy of elemental diet for esophageal cancer chemotherapy
Scientific Title:Acronym
elemental diet for oral mucositis
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy for oral mucositis on esophageal cancer chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevention for oral mucositis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Elemental diet and Glutamine group
Interventions/Control_2
Glutamine group
Interventions/Control_3
Normal diet group
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
PS<3
FEV1.0>1500ml
ASA<2
Key exclusion criteria
PS>3
FEV1.0<1500ml
ASA>2
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yoshida |
Organization
Gifu University
Division name
surgical oncology
Zip code
Address
Gifu city
TEL
058-230-6000
yoshihirotana11@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yoshihirotanaka |
Organization
gifu university
Division name
surgical oncology
Zip code
Address
Yanagido 1-1 Gifu
TEL
0582326000
Homepage URL
yoshihirotana11@hotmail.com
Sponsor or person
Institute
Gifu university surgical oncology
Institute
Department
Personal name
Funding Source
Organization
Gifu university surgical oncology
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
| 2012 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 04 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009816
