UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006201
Receipt number R000007333
Scientific Title Evaluation of oral erosion and prevention by Hangeshashinto in chemotherapy for esophageal cancer
Date of disclosure of the study information 2011/08/19
Last modified on 2015/11/16 18:30:10

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Basic information

Public title

Evaluation of oral erosion and prevention by Hangeshashinto in chemotherapy for esophageal cancer

Acronym

Evaluation of oral erosion and prevention by Hangeshashinto in chemotherapy for esophageal cancer

Scientific Title

Evaluation of oral erosion and prevention by Hangeshashinto in chemotherapy for esophageal cancer

Scientific Title:Acronym

Evaluation of oral erosion and prevention by Hangeshashinto in chemotherapy for esophageal cancer

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Rate of oral erosion

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of oral erosion

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hangeshyashinto

Interventions/Control_2

none

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) squamous cell carcinoma
2) patients to undergo 5-FU(800mg/m2x5days and CDDP 80mg/m2)
3) PS 0-2
4) possible in oral intake of Hangeshashinto
5) 20-year-old or older
6) Adequate organ functions
7) estimated 12 weeks or longer survival
8) Written informed consent

Key exclusion criteria

1) no prior history of allergy in Hangeshashinto
2) patients to undergo other regimen of chemotherapy
3) no prior other Kanpo-drugs administered
4) severe organ failures
5) no prior history of opioids or steroidal treatments
6) active infection
7) concomitant active cancers
8) severe allergy for other drugs
9) patients who want to be pregnant or pregnant woman
10) severe constipation
11) pulmonary fibrosis
12) severe pshychological disorder
13) inappropriate cases for a clinical trials

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisahiro Matsubara

Organization

Chiba University

Division name

Frontier surgery

Zip code


Address

1-8-1, Inohana, chuoku, Chiba

TEL

043-226-2110

Email

matasuhm@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasunori Akutsu

Organization

Chiba University

Division name

Frontier Surgery

Zip code


Address

1-8-1, Inohana, Chuoku, Chiba

TEL

043-226-2110

Homepage URL


Email

yakuts@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba university

Institute

Department

Personal name



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 08 Month 19 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

2011 Year 06 Month 21 Day

Date of IRB


Anticipated trial start date

2011 Year 09 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 08 Month 19 Day

Last modified on

2015 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name