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 | 2026/01/12 11:11:24 |
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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
https://www.jastro.or.jp/member/newsletter/JASTRO_NEWSLETTER_156.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.jastro.or.jp/member/newsletter/JASTRO_NEWSLETTER_156.pdf
Number of participants that the trial has enrolled
14
Results
Fourteen patients were enrolled. During the treatment period, stomatitis Grade 2 was observed in 6 patients (42.9%). Metagenomic analysis showed that 10 of the 14 patients had an increase of more than 4.5% in the presence of Rothia spp. in saliva samples after completion of radiotherapy compared to before radiotherapy.
Results date posted
| 2025 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 14 patients enrolled in this study, 11 were undergoing initial treatment and 3 had postoperative recurrence; 11 were male and 3 were female. The primary tumor sites included the nasopharynx (2 patients), oropharynx (7 patients), hypopharynx (4 patients), larynx (2 patients), parotid gland (1 patient), and unknown primary (1 patient). Histopathological examination revealed squamous cell carcinoma in 13 patients and adenocarcinoma in 1 patient.
Participant flow
Between August 2022 and September 2023, fourteen patients with head and neck cancer were enrolled.
Adverse events
During the course of radiotherapy, Grade 2 oral mucositis was observed in six patients (42.9%), whereas no cases of Grade 3 or higher were reported. Weight loss was documented in 11 out of 14 patients, with a median reduction of -3 kg (range: -1 to -9 kg).
Outcome measures
The median oral V40 Gy and mean dose were 26.2% (range: 3.9-70.2) and 30.8 Gy (range: 18.8-50.0), respectively. Metagenomic analysis revealed that in 10 out of 14 patients, the relative abundance of Rothia species in post-radiotherapy saliva samples increased by more than 4.5% compared with pre-treatment levels. Although the difference was small, patients with Grade 2 oral mucositis tended to have a higher baseline abundance of Oribacterium sinus in pre-treatment saliva samples than those with Grade 1 mucositis. Due to variability in the quality and quantity of collected saliva samples, the number of patients in whom microorganisms above the PCR detection threshold could be confirmed before and after radiotherapy varied, but analysis was feasible in 5 to 9 patients. Comprehensive bacterial analysis by PCR demonstrated a significant reduction in microbial counts in saliva samples after radiotherapy (p = 0.0367). Although not statistically significant, among the five patients in whom microbial detection was possible before and after treatment, four exhibited an increase in P. gingivalis and three showed an increase in C. albicans following radiotherapy. No microorganisms were found to correlate with oral radiation dose or weight loss in this study.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 15 | Day |
Other
Other related information
Salivary analysis conducted before and after radiotherapy for head and neck cancer revealed alterations in the oral microbiota. In certain patients, an increased prevalence of Porphyromonas gingivalis and Candida albicans was observed following radiotherapy, suggesting that radiation therapy may serve as a contributing factor to oral dysbiosis.
Management information
Registered date
| 2022 | Year | 07 | Month | 11 | Day |
Last modified on
| 2026 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055081
