UMIN-CTR Clinical Trial

Basic information
Public title	The impact of the commencement time of hydrogel wound covering/protective material (Episil) for oral mucositis caused by chemotherapy and radiotherapy on cancer patients and cancer treatments. - A prospective observational study -
Acronym	An observational study on Episil for chemotherapy and radiotherapy.
Scientific Title	The differences in effectiveness of hydrogel wound covering/protective material (Episil) for oral mucositis caused by chemotherapy and chemoradiotherapy due to the commencement time. - A prospective observational study -
Scientific Title:Acronym	An observational study on the appropriate time of Episil commencement for oral mucositis caused by chemotherapy and chemoradiotherapy.
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	To evaluate the differences in effectiveness of hydrogel wound covering/protective material for oral mucositis due to the commencement time.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Oral pain
Key secondary outcomes	Oral mucositis Body weight Administration of opioid Blood test results

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Allogeneic hematopoietic stem cell transplant patients and head and neck chemo-radiotherapy patients. 2)Patients who are considered to be appropriate using hydrogel wound covering/protection material.
Key exclusion criteria	1)Oral cancer patients. 2)Patients with wounds except for oral mucositis caused by chemotherapy or radiotherapy. 3)Patients with pain management using opioids before the commencement of hydrogel wound covering/protection material application. 4)Patients who are determined to be inappropriateb y the attending physician.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Kouji Middle name Last name Katsura
Organization	Niigata University Medical and Dental Hospital
Division name	Department of Oral Radiology
Zip code	951-8520
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata city, Niigata, Japan
TEL	025-223-6161
Email	katsu@dent.niigata-u.ac.jp

Public contact
Name of contact person	1st name Kouji Middle name Last name Katsura
Organization	Niigata University Medical and Dental Hospital
Division name	Department of Oral Radiology
Zip code	951-8520
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata city, Niigata, Japan
TEL	025-223-6161
Homepage URL
Email	katsu@dent.niigata-u.ac.jp

Sponsor
Institute	NIigata University
Institute
Department

Funding Source
Organization	None
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	Niigata University Medical and Dental Hospital
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata city, Niigata, Japan
Tel	025-227-2625
Email	ethics@adm.niigata-u.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	2020 Year 08 Month 19 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	45
Results	When our results compare with that of historical control, the degree of pain was better than both the expected value and the threshold value of our setting. The incidence of grade 3 oral mucositis was 14%, which was lower than the incidence of chemoradiotherapy and IMRT.
Results date posted	2022 Year 02 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Head and neck chemoradiotherapy patients
Participant flow	considaration of main docter
Adverse events	NOne
Outcome measures	Pain, mucositis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 09 Month 01 Day
Date of IRB	2019 Year 10 Month 01 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Approval ID: 2019-0001

Management information
Registered date	2020 Year 08 Month 19 Day
Last modified on	2022 Year 02 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047313