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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031921
Receipt No. R000036434
Scientific Title A preliminary study of the effects of a new oral mucosa protective material on chemotherapy- and/or radiation-induced oral mucositis
Date of disclosure of the study information 2018/03/30
Last modified on 2019/03/28

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Basic information
Public title A preliminary study of the effects of a new oral mucosa protective material on chemotherapy- and/or radiation-induced oral mucositis
Acronym A preliminary study of a new oral mucosa protective material
Scientific Title A preliminary study of the effects of a new oral mucosa protective material on chemotherapy- and/or radiation-induced oral mucositis
Scientific Title:Acronym A preliminary study of a new oral mucosa protective material
Region
Japan

Condition
Condition Chemotherapy- and/or radiation-induced oral mucositis
Classification by specialty
Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To preliminarily assess the local analgesic effect, feeling of application and adverse event/ device deficiency of a new medical device, episil(r) oral liquid, on chemotherapy- and/or radiation-induced oral mucositis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in the pain intensity in the oral cavity during 2 hours after a single application of episil(r) , assessed by numerical rating scale score. Change in the effect on improvement in difficulties in food taking and speaking.
Key secondary outcomes Feeling of application of episil(r) , use of rescue mediation, and the incidence of adverse events and device deficiencies

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
Device,equipment
Interventions/Control_1 A single application of episil(R) oral liquid by 3 pump strokes (0.45 mL) to affected area
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients aged >= 20 years of age at the date of obtaining informed consent
2) Patients who are suffering from oral mucositis due to chemotherapy and/or radiotherapy or conditioning regimens prior to a hematopoietic stem cell transplantation
3) Patients who are suffering from pain; caused by oral mucositis, at a maximum of continued pain and spike pain inside the oral cavity, assessed by Universal Pain Assessment Tool results in at least 5 of Likert scale (0~10) at the start of application of episil(r).
4) Patients at good performance status; eg., at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3.
5) Patients have no allergy to any ingredient in episil(r)
Key exclusion criteria 1) Patients have tumor region inside oral cavity
2) Patients have severely injured area not due to oral mucositis
3) Patients who are known or suspected CNS tumor, metastasis or invasion to the CNS
4) Patients have started the rescue medications on Day 1 prior to the application of episil(r).
5) Patients who are participating in other clinical trials
6) Female patients who are breast-feeding, pregnancy or planned pregnancy
7) Patients with considerable concern for compliance with the protocol, in the judgment of investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Takao
Middle name
Last name Ueno
Organization National Cancer Center Hospital
Division name Department of Dentistry
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL +81-3-3547-5201
Email taueno@ncc.go.jp

Public contact
Name of contact person
1st name Takao
Middle name
Last name Ueno
Organization National Cancer Center Hospital
Division name Department of Dentistry
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL +81-3-3547-5201
Homepage URL
Email taueno@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Solasia Pharma K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Hospital
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
Tel +81-3-3547-5201
Email irst@ml.res.ncc.go.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
2018 Year 03 Month 30 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 10
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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 13 Day
Date of IRB
2018 Year 03 Month 15 Day
Anticipated trial start date
2018 Year 03 Month 28 Day
Last follow-up date
2018 Year 05 Month 10 Day
Date of closure to data entry
2018 Year 05 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 01 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036434

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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