UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047845 |
|---|---|
| Receipt number | R000054544 |
| Scientific Title | Environmental Contamination by Aerosols in Radiotherapy Rooms during Head and Neck Radiotherapy |
| Date of disclosure of the study information | 2022/05/24 |
| Last modified on | 2025/05/26 13:24:53 |
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Basic information
Public title
Environmental Contamination by Aerosols in Radiotherapy Rooms during Head and Neck Radiotherapy
Acronym
Environmental contamination by aerosols in radiation therapy rooms
Scientific Title
Environmental Contamination by Aerosols in Radiotherapy Rooms during Head and Neck Radiotherapy
Scientific Title:Acronym
Environmental contamination by aerosols in radiation therapy rooms
Region
| Japan |
Condition
Condition
non-handicapped person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find out the characteristics of air contamination in radiotherapy rooms (carbon-ion and X-ray) in patients with head and neck cancer.
Basic objectives2
Others
Basic objectives -Others
To study the changes in the number of airborne particles during the onset of cough reflex.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Analyze the dynamics of suspended particulates and quantitatively evaluate the range and amount of attached particulates.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Cough reflex on the radiotherapy table.
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) The applicant is at least 18 years old and has the capacity to consent.
2) The patient does not have difficulty in eating and swallowing.
Key exclusion criteria
1) Those with a history of serious respiratory illness.
2) Inability to follow instructions at the time of the examination due to medical, psychological or other factors.
Target sample size
5
Research contact person
Name of lead principal investigator
| 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
musha@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
Japanese Society for Radiation Oncology
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
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
| 2022 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
https://academic.oup.com/jrr/article/64/2/420/7008807
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/jrr/article/64/2/420/7008807
Number of participants that the trial has enrolled
1
Results
Aerosol reach was significantly greater for loud voice and coughing both at vertical height and the head-to-tail width direction. The radiotherapy staff who were in the presence of the participant sometimes had many particles adhering to their facial area; particle adhesion to the staff was dominated by small size particles. Particle adherence to the irradiation device surface near the ceiling had particles larger than 1 mm.
Results date posted
| 2025 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy Japanese male
Participant flow
The healthy male voluntarily enrolled as the participant in this experiment. The participant provided informed written consent.
Adverse events
none
Outcome measures
The actual area where the particles dispersed was photographed with a high-sensitivity camera and evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054544
