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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012275
Receipt No. R000014357
Scientific Title Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2013/11/15
Last modified on 2016/11/22

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Basic information
Public title Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation
Acronym Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation
Scientific Title Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation
Region
Japan

Condition
Condition Hematological malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of Hangeshashinto for prevention of oral mucositis associated with hematopoietic stem cell transplantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of CTCAE Grade3<=oral mucositis
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of Hangeshashinto 7.5g/day t.i.d. after meals.
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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) acute leukemia, adult T cell leukemia/lymphoma, myelodysplastic syndrome, multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's lymphoma.
2) Performance status : Eastern Cooperative Oncology Group (ECOG)<3
3) Patients must have adequate cardiac, hepatic, renal, and pulmonary functions.
Key exclusion criteria 1) Patients seropositive for HIV or HBs.
2) Severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study.
3) Pregnant or breastfeeding women.
4) Patient has another progressive malignant disease.
5) Uncontrolled infections.
6) Acute Myocardial Infarction and heart failure within the last 12 months.
7) Liver cirrhosis.
8) BMI>=35.
9) Arrhythmias: CTCAE v4.0 Grade>=3.
10) Contraindication of Hangeshashinto.
11) Oral mucositis: CTCAE v3.0 Grade>=3.
12) Patients who, in the judgment of the investigator, would be inappropriate for entry into this study.
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Okada
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
Address Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-7214
Email okada@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Okada
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
Address Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-7214
Homepage URL
Email okada@med.hokudai.ac.jp

Sponsor
Institute North Japan Hematology Study Group
Institute
Department

Funding Source
Organization North Japan Hematology Study Group
Organization
Division
Category of Funding Organization Other
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 11 Month 15 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 Completed
Date of protocol fixation
2013 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 12 Day
Last modified on
2016 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014357

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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