UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031921 |
|---|---|
| Receipt number | 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 | 2022/04/07 09:02:54 |
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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
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
taueno@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036434
