UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036616 |
|---|---|
| Receipt number | R000041717 |
| Scientific Title | Juzendaihoto administration for esophageal cancer patients |
| Date of disclosure of the study information | 2019/04/26 |
| Last modified on | 2019/04/26 22:52:08 |
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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
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
akira-br@infoseek.jp
Public contact
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
akira-br@infoseek.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041717
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
