UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007960 |
|---|---|
| Receipt number | R000008400 |
| Scientific Title | Prophylactic effect of elemental diet (Elental) on stomatitis in chemo(-radio)therapy to patients with advanced or recurrent esophageal cancer |
| Date of disclosure of the study information | 2012/05/15 |
| Last modified on | 2015/10/11 13:19:15 |
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Basic information
Public title
Prophylactic effect of elemental diet (Elental) on stomatitis in chemo(-radio)therapy to patients with advanced or recurrent esophageal cancer
Acronym
Prophylactic effect of Elental on stomatitis in chemo(-radio)therapy for esophageal cancer
Scientific Title
Prophylactic effect of elemental diet (Elental) on stomatitis in chemo(-radio)therapy to patients with advanced or recurrent esophageal cancer
Scientific Title:Acronym
Prophylactic effect of Elental on stomatitis in chemo(-radio)therapy for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Frequency or severity of oral erosion
Nutrition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The grade of stomatitis by NCI-CTCAE ver. 4.0
Serum total protein, albimin, T-cholesterol, trigriceride, hemoglobin
Key secondary outcomes
QOL by EORTC-QLQ C30
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Elental
Interventions/Control_2
Sodium gualenate hydrate
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 confirmed esophageal cancer
2.over 20 and under 80 years of age
3. PS 0-2
4. No prior chemo(-radio)therapy within 6 months
5. Adequate oragn functions
6. Written informed consent
Key exclusion criteria
1. Active infection
2. Presence of ileus
3. Treatment with intravenous hyperalimentation
4. Receiving other enteral alimentation
5. Presence of uncorolled diabetes
6. Inappropriate cases
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kokura |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
Kwaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
s-kokura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ishikawa |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
Kwaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
Homepage URL
iskw-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Cancer Immuno Cell
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
| 2012 | Year | 05 | Month | 15 | 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 | 11 | Month | 07 | 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
| 2012 | Year | 05 | Month | 15 | Day |
Last modified on
| 2015 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008400
