UMIN-CTR Clinical Trial

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	https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000036434
Publication of results	Published

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000036434
Number of participants that the trial has enrolled	10
Results	Compared to baseline, the mean NRS began to decrease at 5 mins after using Episil ,and this effect lasted up to 120 minutes. The protective effects of Episil were observed already 3 to 5 minutes after application.Some patients felt slight soreness or discomfort when applying Episil.
Results date posted	2021 Year 03 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 02 Month 01 Day
Baseline Characteristics	1) patients aged 20 years or older (at the time of informed consent) 2) patients with oral mucositis due to chemotherapy, radiotherapy, combination of both (chemoradiotherapy), or pretreatment therapy for hematopoietic stem cell transplantation 3) patients with a pain score under 5 when starting episil 4) patients with good general activity status 5) patients with no allergy to any episil oral liquid components
Participant flow	Episil was used once, (pressing the pump 3 times) to apply the solution to the affected area in the oral cavity for the patient. After evaluating the efficacy profile over 120 minutes after the use of episil, continuous use of episil was allowed if the patient wished to continue, and the investigator considered it usable and necessary. The use of episil was limited to up to 30 days from the start of its use or until one bottle was used up, whichever was shorter. Adverse events and problems were monitored throughout the same period.
Adverse events	-
Outcome measures	A numerical rating scale (NRS) was used to assess oral pain intensity due to OM.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 Year 04 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036434