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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023825
Receipt No. R000027420
Scientific Title An exploratory study on the efficacy and safety of Hangesyasinto (TJ-14) for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in the patients with advanced esophageal cancer.
Date of disclosure of the study information 2016/08/29
Last modified on 2017/09/25

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Basic information
Public title An exploratory study on the efficacy and safety of Hangesyasinto (TJ-14) for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in the patients with advanced esophageal cancer.
Acronym Effect of Hangesyasinto for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in patients with advanced esophageal cancer.
Scientific Title An exploratory study on the efficacy and safety of Hangesyasinto (TJ-14) for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in the patients with advanced esophageal cancer.
Scientific Title:Acronym Effect of Hangesyasinto for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in patients with advanced esophageal cancer.
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore whether Hangesyasinto (TJ-14) is effective and safe and for DCF chemotherapy or DCF-RT chemoradiotherapy induced diarrhea in patients with advanced esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Stool frequency for 4 weeks after the start of administration
Key secondary outcomes 1. Period and incidence rate of diarrhea more than CTCAE Grade2 for 4 weeks after administration
2. Stool consistency (Bristol stool scale) for 4 weeks after administration
3. Diamine oxidase activity [Before administration, at week 1 and 4]
4. The number of completion patients of DCF chemotherapy or DCF-RT chemoradiotherapy
5.Adverse event/reactions

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TJ-14 TSUMURA Hangeshashinto Extract Granules for Ethical Use. Oral administration of Hangeshashinto (7.5g/day t.i.d. before meals) for 4 weeks after the start of 2nd course of DCF chemotherapy or DCF-RT chemoradiotherapy.
Interventions/Control_2 Non-Hangeshashinto-treated
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. confirmed esophageal cancer by histological diagnosis
2. developed diarrhea more than CTCAE Grade1 on the 1st course of DCF chemotherapy or DCR-RT chemoradiotherapy
3. stage 2-4 of esophageal cancer progression
4. survival is expected for three months at least after administration
5. Performance Status 0-2
6. No dysfunction of major organs (heart, lung, liver, kidney, and bone marrow)
7. hospitalization
8. have given written informed consent to participate in this study
Key exclusion criteria 1. aldosteronism
2. myopathy or hypokalemia
3. while taking the Kampo medicines
4. less than 4 weeks after previous chemo or radio completion
5. medical history of serious drug allergy
6. presence of serious complications (heart, lung, liver, or kidney disease or psychological disorders or bleeding)
7. HBV, HCV infection
8. pregnant or breast-feeding females and females who have a possibility of pregnancy
9. patients who are thought inadequate by their doctor
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki kato
Organization Dokkyo Medical University
Division name Department of Surgery 1
Zip code
Address 880, Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293
TEL 0282-86-1111
Email hkato@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanobu nakajima
Organization Dokkyo Medical University
Division name Department of Surgery 1
Zip code
Address 880, Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293
TEL 0282-86-1111
Homepage URL
Email mnakajim@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization TSUMURA & CO.
Organization
Division
Category of Funding Organization Profit 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
2016 Year 08 Month 29 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 10 Month 30 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2017 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027420

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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