UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012275 |
|---|---|
| Receipt number | 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 13:17:33 |
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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
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
okada@med.hokudai.ac.jp
Sponsor or person
Institute
North Japan Hematology Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014357
