UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045409 |
|---|---|
| Receipt number | R000051849 |
| Scientific Title | A study on the prevention of exacerbation of oral mucositis by early initiation of Episil oral liquid in hematopoietic stem cell transplant recipients and head and neck cancer patients |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2021/09/07 18:33:15 |
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Basic information
Public title
A study on the prevention of exacerbation of oral mucositis by early initiation of Episil oral liquid in hematopoietic stem cell transplant recipients and head and neck cancer patients
Acronym
A study on the prevention of exacerbation of oral mucositis by early initiation of Episil oral liquid
Scientific Title
A study on the prevention of exacerbation of oral mucositis by early initiation of Episil oral liquid in hematopoietic stem cell transplant recipients and head and neck cancer patients
Scientific Title:Acronym
A study on prevention of oral mucositis exacerbation by early initiation of Episil oral liquid
Region
| Japan |
Condition
Condition
Head and neck cancer, Hematological malignancy
Classification by specialty
| Hematology and clinical oncology | Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of early initiation of Episil Oral liquid on the prevention of exacerbation of oral mucositis in patients with hematopoietic stem cell transplantation and head and neck cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral mucositis pain (every week from the start of treatment, up to 4 weeks from the end of treatment)
Key secondary outcomes
Severity of oral mucositis, Nutritional assessment, Eating Status Scale, Pain control, usability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use Episil after the detection of Grade 1 oral mucositis (CTCAE v.5)
Interventions/Control_2
Use Episil after the detection of Grade2 or higher oral mucositis (CTCAE v.5)
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) Hematopoietic stem cell transplant patients
2) Head and neck chemo-radiotherapy patients
Key exclusion criteria
1) Patients who need assistance in using Episil.
2) Patients with lesions including the central nervous system (CNS), or having confirmed/suspected of metastasis/invasion in the CNS
3) Patients using opioids for pain management prior to the start of Episil administration.
4) Patients with serious infections or complication.
5) Patients with known allergy to any of the ingredients in Episil.
6) Patients judged to be inappropriate by the investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Satoh |
Organization
Fujita Health University
Division name
Department of Dentistry and Oral-maxillofacial Surgery, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2210
kjsato@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Mutsumi |
| Middle name | |
| Last name | Yamakoshi |
Organization
Fujita Health University Hospital
Division name
Department of Dentistry and Oral-maxillofacial Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2210
Homepage URL
yama-dh@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Self-funding costs
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
Fujita Health University Institutional Research Board
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2862
f-irb@fujita-hu.ac.jp
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
| 2021 | Year | 09 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051849
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| Registered date | File name |
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| Registered date | File name |
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