UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004898 |
|---|---|
| Receipt number | R000005518 |
| Scientific Title | A randomized trial of effect of elemental diet (Elental) to stomatitis and diarrhea in chemotherapy to patients with esophageal cancer |
| Date of disclosure of the study information | 2011/01/31 |
| Last modified on | 2011/01/19 13:10:22 |
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Basic information
Public title
A randomized trial of effect of elemental diet (Elental) to stomatitis and diarrhea in chemotherapy to patients with esophageal cancer
Acronym
A randomized trial of effect of elemental diet (Elental) to stomatitis and diarrhea in chemotherapy to patients with esophageal cancer
Scientific Title
A randomized trial of effect of elemental diet (Elental) to stomatitis and diarrhea in chemotherapy to patients with esophageal cancer
Scientific Title:Acronym
A randomized trial of effect of elemental diet (Elental) to stomatitis and diarrhea in chemotherapy to patients with esophageal cancer
Region
| Japan |
Condition
Condition
Stomatitis and diarrhea in chemotherapy to patients with esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In chemotherapy, there is found gastrointestinal symptoms such as stomatitis and diarrhea, which may lead to reduced compliance and adherence to chemotherapy.
Elental could reduce the side-effects such as stomatitis and diarrhea by the effects of amino acids contained in Elental and feature that is easily absorbed.
Therefore, we investigate the effect of Elental against stomatisis and diarrhea with esophageal cancer chemotherapy by the use of non-dose group compared with Elental.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The grade of stomatitis and diarrhea by NCI-CTCAE ver.4.0 (1 and 2 weeks after the beginning of administration)
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Elental (Ajinomoto Pharmaceuticals Co., Ltd. Tokyo) administered orally one package daily for two weeks from the date of the start of chemotherapy
Interventions/Control_2
No treatment group
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) Patient with esophageal cancer in chemotherapy
2) Patient whose age is more than twenty.
3) Patient who gives written informed concent.
Key exclusion criteria
1) Patient in radiotherapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Nishikage, M.D. |
Organization
Tokyo Medical and Dental University
Division name
Department of Esophagogastric surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical and Dental University
Division name
Department of Esophagogastric surgery
Zip code
Address
TEL
03-5803-5688
Homepage URL
Sponsor or person
Institute
Tokyo Medical and Dental 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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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 | 01 | Month | 19 | Day |
Last modified on
| 2011 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005518
