UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of quality of life (QOL) improvement by moisturizer to radiation dermatitis accompanying radiation therapy after breast conserving surgerysurgery
Title of the study (Brief title)	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	Jiro Kawamori
Organization	St.Luke International Hospital
Division name	Department of Radiation Oncology
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	Jiro Kawamori
Organization	St.Luke International Hospital
Division name	Department of Radiation Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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