UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028797
Receipt No. R000031047
Scientific Title Examination of radiation oral mucositis reduction effect by using intraoral stent.
Date of disclosure of the study information 2017/08/25
Last modified on 2018/04/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Examination of radiation oral mucositis reduction effect by using intraoral stent.
Acronym Examination of radiation oral mucositis reduction effect by using intraoral stent.
Scientific Title Examination of radiation oral mucositis reduction effect by using intraoral stent.
Scientific Title:Acronym 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
1st name
Middle name
Last name Moridera Kuniyasu
Organization Hyogo College of Medicine
Division name Department of Dentistry and Oral Surgery
Zip code
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
1st name
Middle name
Last name Moridera Kuniyasu
Organization Hyogo College of Medicine
Division name Department of Dentistry and Oral Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 14 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000031047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.