UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044898 |
|---|---|
| Receipt number | R000051282 |
| Scientific Title | Study on the effect of radiotherapy on skin barrier function |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2025/10/06 12:17:46 |
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Basic information
Public title
Study on the effect of radiotherapy on skin barrier function
Acronym
Study on the effect of radiotherapy on skin barrier function
Scientific Title
Study on the effect of radiotherapy on skin barrier function
Scientific Title:Acronym
Study on the effect of radiotherapy on skin barrier function
Region
| Japan |
Condition
Condition
Malignant Tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of radiotherapy on skin barrier function using skin measurement data before and after radiotherapy
Basic objectives2
Others
Basic objectives -Others
The effect of radiotherapy on the skin barrier function will be investigated using pre- and post-treatment skin measurement data from patients treated with more than 40 Gy of radiotherapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the moisture content and oil content of the patient's skin
Key secondary outcomes
Correlation of changes in measured values with concomitant therapy, radiotherapy energy, and irradiation method,Comparison of skin barrier function by surgical techniques
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
1) Patients over 20 years old
2) Patients with no previous history of radiation therapy.
3) Patients who are scheduled to receive radiotherapy with a total dose of 40 Gy or more.
Key exclusion criteria
1) Patients with concomitant active dermatological diseases for which oral or topical medication is used
2) Patients with serious complications (liver cirrhosis, diabetes, heart disease, etc.)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Itonaga |
Organization
Tokyo Medical University
Division name
Department of radiology
Zip code
160-0023
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
itonaga@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Itonaga |
Organization
Tokyo Medical University
Division name
Department of radiology
Zip code
160-0023
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
itonaga@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokyo Medical University
Address
160-0023 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
IRB@tokyo-med.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 | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Skin moisture, oil, and pH data will be measured on the skin of the irradiated area using a pen-type skin measurement device. Specifically, measurements will be taken before treatment, during treatment, and one month after treatment, as well as at outpatient timing, and a gross dermatitis evaluation using the CTCAE ver5.0 will be performed.
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051282
