UMIN-CTR Clinical Trial

Basic information
Public title	Juzendaihoto administration for esophageal cancer patients
Acronym	Juzendaihoto administration for esophageal cancer patients
Scientific Title	Juzendaihoto administration for esophageal cancer patients
Scientific Title:Acronym	Juzendaihoto administration for esophageal cancer patients
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to analyze whether the patient's immune and nutritional status can be improved and the occurrence of complications can be suppressed by taking oral administration of Chuzen-daiho-to when treating esophageal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Incidence of postoperative complications Postoperative complications: respiratory complications, suture failure, recurrent nerve paralysis
Key secondary outcomes	Assessment of immune and nutritional status by blood and biochemical tests (Lymphocyte count, neutrophil count, monocyte count, platelet count, serum albumin level, CRP) (before chemotherapy, before surgery, 2 months after surgery)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Jyuzendaihoto administration
Interventions/Control_2
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Target patients who meet all the following criteria: 1 Age: At the time of obtaining consent, patients aged 20 to 85 years old 2 Gender: Any question 3 hospitalization / outpatient: hospitalization / outpatient 4 Patients who are scheduled to undergo esophagectomy after preoperative chemotherapy between the date of study approval and December 31, 2023 5 Patients who received informed consent for participating in this study and who obtained written consent by the patient's free will or who obtained consent of a representative after thorough understanding
Key exclusion criteria	1 Cases in which preoperative chemotherapy or surgery could not be performed 2 Patients with drug hypersensitivity and allergies 3 Pregnant women and patients who may be pregnant or nursing 4 Other patients who the research director judged inappropriate as the research subject
Target sample size	35

Research contact person
Last name of lead principal investigator	1st name Susumu Middle name Last name Eguchi
Organization	Nagasaki University
Division name	Department of Surgery
Zip code	850-8501
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7316
Email	akira-br@infoseek.jp

Public contact
1st name of contact person	1st name Akira Middle name Last name Yoneda
Organization	Nagasaki University
Division name	Department of Surgery
Zip code	850-8501
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7316
Homepage URL
Email	akira-br@infoseek.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University
Address	1-7-1 Sakamoto,, Nagasaki
Tel	0958197316
Email	akira-br@infoseek.jp

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	2019 Year 04 Month 26 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	Preinitiation
Date of protocol fixation	2019 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date	2019 Year 05 Month 15 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 26 Day
Last modified on	2019 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041717