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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006201
Receipt No. 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

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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
Institute Chiba university
Institute
Department

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
URL(English) https://upload.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


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