UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048332 |
|---|---|
| Receipt number | R000055081 |
| Scientific Title | Prospective observational study on changes in the microbial flora of the oral cavity following head and neck radiotherapy for the establishment of oral hygiene management. |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2024/01/11 09:53:18 |
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Basic information
Public title
Prospective observational study on changes in the microbial flora of the oral cavity following head and neck radiotherapy for the establishment of oral hygiene management.
Acronym
The microbial flora and head and neck radiotherapy
Scientific Title
Prospective observational study on changes in the microbial flora of the oral cavity following head and neck radiotherapy for the establishment of oral hygiene management.
Scientific Title:Acronym
The microbial flora and head and neck radiotherapy
Region
| Japan |
Condition
Condition
Head and neck cancer patients
Classification by specialty
| Oto-rhino-laryngology | Radiology | Dental medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to observe the change in oral microbial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the severity of mucositis.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to observe the change in oral microbial flora during radiotherapy and investigate the relationship between the type of specific bacterias and the severity of mucositis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the relationship between the type of specific bacterias and the severity of radiation-induced acute mucositi.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age between 20 and 80
(2) ECOG PS 0-2
(3) Head and neck cancer patients (nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, nasal/paranasal cavity cancer, laryngeal cancer, salivary gland cancer) who will receive primary radiation therapy.
(4) Informed consent is obtained from the patients.
Key exclusion criteria
(1) Patients with active bacterial or fungal infection in the oral cavity.
(2) Patients with a mental impairment who has not the ability to participate in the clinical study.
(3) Patients whom the attending physician deemed not appropriate to participate in the clinical trial.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Igaki |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
Chuo-ku, TSukiji 5-1-1, Tokyo, Japan
TEL
+81-33542-2511
hirigaki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Murakami |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
Chuo-ku, Tsukiji 5-1-1, Tokyo, Japan
TEL
+81-33542-2511
Homepage URL
ore.murakami@gmail.com
Sponsor or person
Institute
Department of Radiation Oncology, National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Radiation Oncology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Infectious Diseases
Name of secondary funder(s)
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
Chuo-ku, Tsukiji 5-1-1, Tokyo, Japan
Tel
+81-33542-2511
ore.murakami@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-573
Org. issuing International ID_1
National Cancer Center Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Results obtained from the observation study will be written.
Management information
Registered date
| 2022 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055081
