UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026190 |
|---|---|
| Receipt number | R000030089 |
| Scientific Title | Comparative study to evaluate the preventive effect of moisturizing agent(heparinoid) for radiation dermatitis in head and neck cancer. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/08/21 21:15:53 |
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Basic information
Public title
Comparative study to evaluate the preventive effect of moisturizing agent(heparinoid) for radiation dermatitis in head and neck cancer.
Acronym
Comparative study to evaluate the preventive effect of moisturizing agent(heparinoid) for radiation dermatitis in head and neck cancer.
Scientific Title
Comparative study to evaluate the preventive effect of moisturizing agent(heparinoid) for radiation dermatitis in head and neck cancer.
Scientific Title:Acronym
Comparative study to evaluate the preventive effect of moisturizing agent(heparinoid) for radiation dermatitis in head and neck cancer.
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventive effect of Heparinoid against radiation dermatitis using from the beginning of radiotherapy for head and neck cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence rate of radiation dermatitis over Grade 2(CTCAE ver. 4.0)
Key secondary outcomes
1)The time to incidence of radiation dermatitis over Grade 2
2)The highest grade of radiation dermatitis during observation period
3)Time course of QOL about skin symptom
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Applying hirudoid soft ointment to the irradiated field twice daily beginning on the first day of radiation therapy, continuing throughout treatments (about 6-7weeks).
Interventions/Control_2
Observation
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)head and neck cancer(oral cavity, pharynx, or larynx) and planned to receive over 50Gy radiotherapy
2)Lack of previous radiotherapy for head and neck field
3)More than 20 years old at the time of the agreement acquisition
4)Written informed consent to participate in this study
Key exclusion criteria
1)Early glottis carcinoma (T1-2N0)
2)Planned use of cetuximab
3)inflammatory or connective tissue disorder of the skin
4)hemorrhagic disease
5)psychiatric disease or psychiatric symptom
6)ineligible status judged by attending doctor
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Mio |
| Middle name | |
| Last name | Kojima |
Organization
Tokyo medical and dental university
Division name
Department of radiation oncology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-5311
kjmmrad@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Mio |
| Middle name | |
| Last name | Kojima |
Organization
Tokyo medical and dental university
Division name
Department of radiation oncology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-5311
Homepage URL
kjmmrad@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university
Department of radiation oncology
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and dental university
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
IRB of Tokyo medical and dental university
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0338136111
tiken.crc@tmd.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
東京医科歯科大学医学部附属病院(東京都) / Medical hospital, Tokyo medical and dental university
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
| 2017 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2019 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030089
