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

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 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


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

Value
https://center6.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