UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017741 |
|---|---|
| Receipt number | R000020552 |
| Scientific Title | Treatment of radiation dermatitis |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2018/10/14 10:43:43 |
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Basic information
Public title
Treatment of radiation dermatitis
Acronym
Treatment of radiation dermatitis
Scientific Title
Treatment of radiation dermatitis
Scientific Title:Acronym
Treatment of radiation dermatitis
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of an effective treatment for radiation dermatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Grade of radiation dermatitis (CTCAE v.4)
Key secondary outcomes
Scale of pain and itching of cervical skin
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
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
washing practice, moisturizing agent and Topical steroid cream
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who receive radiation therapy for head and neck cancer
Key exclusion criteria
Patients who have allergy for topical agents
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Yumoto |
Organization
Kumamoto University Graduate School of Medicine
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL
096-373-5255
jibika-ikyoku@fc.kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daizo Murakami |
Organization
Kumamoto University Graduate School of Medicine
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL
096-373-5255
Homepage URL
http://www2.kuh.kumamoto-u.ac.jp/jibiinkoka/
daizo0823@gmail.com
Sponsor or person
Institute
Kumamoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University Graduate School of Medicine
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
Address
Tel
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
熊本大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 14 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 14 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020552
