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

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 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


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

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
Registered date File name

Research case data
Registered date File name