UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045472 |
|---|---|
| Receipt number | R000051914 |
| Scientific Title | An Exploratory Study on the Mechanism and prevention of Radiation-Induced Oral Mucositis |
| Date of disclosure of the study information | 2021/09/22 |
| Last modified on | 2024/03/16 10:14:52 |
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Basic information
Public title
An Exploratory Study on the Mechanism and prevention of Radiation-Induced Oral Mucositis
Acronym
Mechanism and prevention of Radiation-Induced Oral Mucositis
Scientific Title
An Exploratory Study on the Mechanism and prevention of Radiation-Induced Oral Mucositis
Scientific Title:Acronym
Mechanism and prevention of Radiation-Induced Oral Mucositis
Region
| Japan |
Condition
Condition
Head and neck cancer patients undergoing radiotherapy or chemoradiotherapy
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Whether local infection of oral bacteria or excessive cytokine production is involved in the exacerbation of oral mucositis during radiotherapy or chemoradiotherapy for head and neck cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial counts in oral mucositis and periodontal pockets
Inflammatory cytokines in the oral mucositis and periodontal pockets
Severity of oral mucositis
Key secondary outcomes
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
Patients with head and neck cancer who underwent radiotherapy in which the oral cavity was included in the irradiation field at Nagasaki University Hospital the date of approval by the hospital April 30, 2023, and who can be followed up during the irradiation period will be eligible.
Key exclusion criteria
Irradiation of less than 50 Gy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Oral Health
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197698
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Oral Health
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197698
Homepage URL
sakiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
The Institutional Review Board (IRB) of Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
| 2021 | Year | 09 | Month | 22 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
periodontal disease
Management information
Registered date
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051914
