UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013183 |
|---|---|
| Receipt number | 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 16:17:14 |
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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
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
hinode@tokushima-u.ac.jp
Sponsor or person
Institute
The university of Tokushima
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
