UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011015 |
|---|---|
| Receipt number | R000012890 |
| Scientific Title | Preventive effect of Hangeshashin-to against oral mucositis in allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2015/06/22 10:35:00 |
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Basic information
Public title
Preventive effect of Hangeshashin-to against oral mucositis in allogeneic hematopoietic stem cell transplantation
Acronym
Hangeshashin-to for oral mucositis in allogeneic HSCT
Scientific Title
Preventive effect of Hangeshashin-to against oral mucositis in allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
Hangeshashin-to for oral mucositis in allogeneic HSCT
Region
| Japan |
Condition
Condition
Patients who receive their first allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of Hangeshashin-to against oral mucositis in allogeneic HSCT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative incidence of grade 2 or more oral mucositis between the start of conditioning regimen and engraftment
Key secondary outcomes
1)Incidence and severity of diarrhea
2)Incidence and duration of febrile neutropenia
3)Frequency and duration of use of intravenous hyperalimentation
4)Duration of engraftment
5)Incidence and severity of acute graft-versus-host disease
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Hangeshashin-to 2.5g t.i.d., from the start of conditioning regimen to engraftment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who receive their first allogeneic HSCT
2)Use of methotrexate for prophylaxis of GVHD
3)Written informed consent
Key exclusion criteria
1)Patients who are not eligible for HSCT
2)Allergy to Hangeshashin-to
3)Patients who cannot take medicine orally, or have grade 2 or more oral mucositis at the start of conditioning regimen
4)Aldosteronism
5)Myopathy
6)Uncontrollable hypokalemia (<3.5 mEq/L)
7)Inadequate condition as diagnosed by primary physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kakihana |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Division name
Hematology division
Zip code
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
+81-3-3823-2101
kakihana@cick.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kakihana |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Division name
Hematology division
Zip code
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
+81-3-3823-2101
Homepage URL
kakihana@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 12 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | 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
| 2013 | Year | 06 | Month | 21 | Day |
Last modified on
| 2015 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012890
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
