UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028797 |
|---|---|
| Receipt number | 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 16:19:31 |
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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
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
k-yasu@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031047
