UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026987 |
|---|---|
| Receipt number | R000030703 |
| Scientific Title | Assessment of quality of life (QOL) improvement by moisturizer to radiation dermatitis accompanying radiation therapy after breast conserving surgerysurgery |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2019/03/04 18:54:12 |
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Basic information
Public title
Assessment of quality of life (QOL) improvement by moisturizer to radiation dermatitis accompanying radiation therapy after breast conserving surgerysurgery
Acronym
QOL improvement by moisturizer to radiation dermatitis
Scientific Title
Assessment of quality of life (QOL) improvement by moisturizer to radiation dermatitis accompanying radiation therapy after breast conserving surgerysurgery
Scientific Title:Acronym
QOL improvement by moisturizer to radiation dermatitis
Region
| Japan |
Condition
Condition
Breast cancer
Radiation dermatitis
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate whether heparinoid application as a humectant contributes to improvement of QOL of patients for radiation skin disorder accompanying radiotherapy after breast-conserving surgery, a randomized controlled trial of moisturizer use group and moisturizer non-use group is conducted .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DLQI total scores at a week after treatment completion
Key secondary outcomes
DLQI total score
DLQI subscale
NCI-CTCAE Grade (radiation dermatitis)
Use of steroid cream
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Moisturizing agent application group
Heparinoid cream
From start of radiation therapy
Twice daily
Using 1FTU on irradiated skin
Interventions/Control_2
Non moisturizing agent application group
No use of any moisturizing cream and topical creams during radiation therapy on irradiated skin.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1)Patients planning to conduct radiation therapy after breast-conserving surgery at our hospital radiotherapy department at a dose of less than a divided dose (dose: 2.66 Gy / day total dose 42.56 Gy irradiation energy: 4 MV or 6 MV) (whether or not boost irradiation is asked Absent)
2)Patients who can understand the Japanese DLQI question and can answer
3)When assigned to a non-moisturizing group, patients who can agree not to apply moisturizing agent for a fixed period
4)Women with age from 40 to 80 who have skin dryness symptoms and a heparin analog containing preparation is indicated
5)Patients who got an explanation about the contents of this research and gained consent in writing about research participation
Key exclusion criteria
1) Patients who are unable to cooperate with DLQI measurement
2) Patients with extensive complications or medical history of the skin, chronic skin disease
3) Patients with a history of hypersensitivity to heparin analogue-containing preparations
4) Patients scheduled to undergo chemotherapy or endocrine therapy during radiation treatment
5) Patients with collagen disease, systemic immune disease, hemorrhagic blood disease
6) Patients who are judged to be ineligible by research director, research assignee
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Kawamori |
Organization
St.Luke International Hospital
Division name
Department of Radiation Oncology
Zip code
Address
9-1, Akashi-cho, Chuo-ku, Tokyo,104-8560,JAPAN
TEL
03-3541-5151
jirokawa@luke.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Kawamori |
Organization
St.Luke International Hospital
Division name
Department of Radiation Oncology
Zip code
Address
9-1, Akashi-cho, Chuo-ku, Tokyo,104-8560,JAPAN
TEL
03-3541-5151
Homepage URL
jirokawa@luke.ac.jp
Sponsor or person
Institute
St.Luke International Hospital
Department of Radiation Oncology
Institute
Department
Personal name
Funding Source
Organization
Mruho Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030703
