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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026987
Receipt No. 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

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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
Email 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
Email jirokawa@luke.ac.jp

Sponsor
Institute St.Luke International Hospital
Department of Radiation Oncology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030703

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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