UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005532 |
|---|---|
| Receipt number | R000006560 |
| Scientific Title | The efficacy of skin-moisturizing agents for radiation dermatitis and basic information associated with radiation dermatitis |
| Date of disclosure of the study information | 2011/04/29 |
| Last modified on | 2013/11/08 14:18:04 |
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Basic information
Public title
The efficacy of skin-moisturizing agents for radiation dermatitis and basic information associated with radiation dermatitis
Acronym
The efficacy of skin-moisturizing agents for radiation dermatitis
Scientific Title
The efficacy of skin-moisturizing agents for radiation dermatitis and basic information associated with radiation dermatitis
Scientific Title:Acronym
The efficacy of skin-moisturizing agents for radiation dermatitis
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of heparinoid for radiation dermatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Change of ratio of stratum corneum hydration after four weeks from end of radiotherapy
Key secondary outcomes
Sebaceous volume, activities of sebaceous glands, objective symptom, subjective symptom, sebaceous component
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Application of heparinoid on the irradiated skin twice a day two weeks after the completion of whole breast irradiation
Interventions/Control_2
No application of heparinoid and other skin-moisturizing agents on the irradiated skin
Interventions/Control_3
Prophylactic application of heparinoid on the irradiated skin twice a day from the start of radiotherapy and continuing it after the completion of whole breast irradiation
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Breast cancer patients who are to be treated with whole breast irradiation
2. no previous radiotherapy
3. written in informed consent
Key exclusion criteria
1. Patients with widespread skin complications
2. Patients who have past history of collagen vascular diseases
3. Patients who were sensitive to heparinoid
4. Patients who were judged unsuitable for this study by the investigator.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sekiguchi |
Organization
St Luke's international Hospital
Division name
Department of Radiation Oncology
Zip code
Address
9-1 Akashicho, Chuo-ku,Tokyo, Japan
TEL
03-5550-7006
kenjisek@luke.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mami Ogita |
Organization
St Luke's international Hospital
Division name
Department of Radiation Oncology
Zip code
Address
9-1 Akashicho, Chuo-ku,Tokyo, Japan
TEL
03-5550-7006
Homepage URL
keikoak@luke.or.jp
Sponsor or person
Institute
Department of Radiation Oncology
St Luke's international Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
聖路加国際病院 St Luke’s International Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 29 | 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
A total of 62 patients were analysed. Before randomization, the affected / contralateral skin water content ratio was 0.97 +/-0.13 at the beginning, 0.79+/-0.15 (p=0.00) at the RT completion, and 0.77 +/-0.15 (p=0.00) two weeks after RT. The difference of skin water content ratio comparing four weeks to two weeks after the completion of RT was 0.242 +/-0.225 in moisturizer group and 0.055 +/- 0.145 in no treatment group (p=0.001); indicating the skin water content was significantly increased in moisturizer group.
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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 09 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 09 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Pain score at three months after RT was less in moisturizer group (0.23 +/-0.90 in moisturizer group and 1.58 +/-3.44 in no treatment group, p=0.026). However, there was no difference in pruritus scores between the groups.
Management information
Registered date
| 2011 | Year | 04 | Month | 29 | Day |
Last modified on
| 2013 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006560
