UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Hiroyuki kato
Organization	Dokkyo Medical University
Division name	Department of Surgery 1
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	Masanobu nakajima
Organization	Dokkyo Medical University
Division name	Department of Surgery 1
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027420