UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050646 |
|---|---|
| Receipt number | R000057360 |
| Scientific Title | Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy: A prospective study |
| Date of disclosure of the study information | 2023/03/22 |
| Last modified on | 2023/03/22 15:34:58 |
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Basic information
Public title
Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy: A prospective study
Acronym
Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy
Scientific Title
Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy: A prospective study
Scientific Title:Acronym
Relationship between radiation-induced oral mucositis and the oral bacterial flora with undergoing radiotherapy
Region
| Japan |
Condition
Condition
Head and neck cancer patients
Classification by specialty
| Oto-rhino-laryngology | Radiology | Oral surgery |
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to observe the change in oral bacterial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the onset of radiation induced mucositis.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to observe the change in oral bacterial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the onset of radiation induced mucositis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To observe the change in oral bacterial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the onset of radiation induced 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A Malignant tumor in the head and neck region.
(2) The lesion is measurable.
3) Radiotherapy is planned.
4) The oral mucosa may be irradiated.
5) The patient is over 18 years of age.
6) Performance Status (PS) is 0-2.
(7) The patient has been informed of the name and condition of the disease and is capable of consenting.
Key exclusion criteria
1) Previous radiation therapy to the area to be treated.
2) Active and refractory infection at the irradiated site.
(3) Severe complications (uncontrolled diabetes, myocardial infarction, unstable angina, uncontrolled arrhythmia, bleeding tendency, collagen disease requiring steroid administration, etc.).
(4) Active multiple cancers (simultaneous multiple cancers and iatrogenic multiple cancers with a disease-free interval of 5 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in the active overlapping cancers.
(5) Previous surgery in the radiotherapy area.
(6) An event occurs during the study period for which radiotherapy should not be initiated.
(7) The patient is found not to have a malignant tumor in the head and neck region after the start of the study.
(8) If it becomes difficult to continue radiotherapy for some reason after the start of the study.
(9) Other medical, psychological, or other factors that make the physician in charge of the patient inappropriate for the study.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University Graduate School of Medicine.
Division name
Department of Radiation Oncology
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8383
tohno@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Musha |
Organization
Gunma University
Division name
Heavy Ion Medical Center
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8378
Homepage URL
musha@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
gunmaciru-office@umin.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
| 2023 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To be registered after analysis is completed.
Management information
Registered date
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057360
