UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of Kampo medicines in chemotherapy-induced oral mucositis for esophageal cancer
Title of the study (Brief title)	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	Daisuke Hinode
Organization	The university of Tokushima graduate school institute of health biosciences
Division name	Department of hygiene and oral health science
Address	18-15 kuramotocho 3-chome, Tokushima
TEL	088-633-7543
Email	hinode@tokushima-u.ac.jp

Public contact
Name of contact person	Daisuke Hinode
Organization	The university of Tokushima graduate school institute of health bioscience
Division name	Department of hygiene and oral health science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015319