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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011015
Receipt No. 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

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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
Email 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
Email kakihana@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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