UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation
Title of the study (Brief title)	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	Kohei Okada
Organization	Hokkaido University Hospital
Division name	Department of Hematology
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	Kohei Okada
Organization	Hokkaido University Hospital
Division name	Department of Hematology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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