UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of radiation oral mucositis reduction effect by using intraoral stent.
Title of the study (Brief title)	Examination of radiation oral mucositis reduction effect by using intraoral stent.
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology Radiology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of intraoral stents which prevent unnecessary irradiation of normal tissue and reduce mucosal damage.
Basic objectives2	Others
Basic objectives -Others	To measure the accuracy of irradiation with and without intraoral stents.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the severity of oral mucositis during radiotherapy
Key secondary outcomes	treatment completion rate, the period for oral intake without pain, prognosis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Participants are scanned using CT unit with and without intraoral stent. Received IMRT or definitve chemoradiotherapy with intraoral stent. From the beginning of radiotherapy, access the severity of oral mucositis once a week.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients who received IMRT or definitve chemoradiotherapy for head and neck tumors
Key exclusion criteria	no criteria
Target sample size	150

Research contact person
Name of lead principal investigator	Moridera Kuniyasu
Organization	Hyogo College of Medicine
Division name	Department of Dentistry and Oral Surgery
Address	1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL	0798-45-6677
Email	k-yasu@hyo-med.ac.jp

Public contact
Name of contact person	Moridera Kuniyasu
Organization	Hyogo College of Medicine
Division name	Department of Dentistry and Oral Surgery
Address	1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL	0798-45-6677
Homepage URL
Email	k-yasu@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 08 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 14 Day
Anticipated trial start date	2017 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 23 Day
Last modified on	2018 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031047