UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023825 |
|---|---|
| Receipt number | 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 17:32:37 |
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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
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
mnakajim@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027420
