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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004898
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005518

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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