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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013183
Receipt No. R000015319
Scientific Title Clinical study of Kampo medicines in chemotherapy-induced oral mucositis for esophageal cancer
Date of disclosure of the study information 2014/04/01
Last modified on 2017/03/31

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Basic information
Public title Clinical study of Kampo medicines in chemotherapy-induced oral mucositis for esophageal cancer
Acronym Clinical study of Kampo medicines in chemotherapy-induced oral mucositis
Scientific Title Clinical study of Kampo medicines in chemotherapy-induced oral mucositis for esophageal cancer
Scientific Title:Acronym Clinical study of Kampo medicines in chemotherapy-induced oral mucositis
Region
Japan

Condition
Condition Oral mucotisis
Classification by specialty
Gastrointestinal surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of Kampo medicines in chemotherapy-induced oral mucositis for esophageal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The grade of stomatitis and diarrhea by NCI-CTCAE ver.4.0
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 NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Hangeshashinto sherbet in the water 7.5g/day t.i.d. between meals
Interventions/Control_2 Daiokanzoto sherbet in the water 7.5g/day t.i.d. between meals
Interventions/Control_3 control
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 cencer in chemotherapy
3)20-year-old or older
4)All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria 1)Clinically significant infection
2)Severe organ failures
3)Serious drug allergy
4)Patients who want to be pregnant or pregnant woman
5)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Hinode
Organization The university of Tokushima graduate school institute of health biosciences
Division name Department of hygiene and oral health science
Zip code
Address 18-15 kuramotocho 3-chome, Tokushima
TEL 088-633-7543
Email hinode@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Hinode
Organization The university of Tokushima graduate school institute of health bioscience
Division name Department of hygiene and oral health science
Zip code
Address 18-15 kuramotocho 3-chome, Tokushima
TEL 088-633-7543
Homepage URL
Email hinode@tokushima-u.ac.jp

Sponsor
Institute The university of Tokushima
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
2014 Year 04 Month 01 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
2014 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 18 Day
Last modified on
2017 Year 03 Month 31 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015319

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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