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Optimal Topical Agent for Radiation Dermatitis During Breast Radiotherapy

Status Approved

First Submitted Date

2017/09/06
Registered Date

2018/02/14
Last Updated Date

2017/12/25

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002695
Unique Protocol ID	GAIRB2017-127
Public/Brief Title	Optimal Topical Agent for Radiation Dermatitis During Breast Radiotherapy
Scientific Title	Optimal Topical Agent for Radiation Dermatitis During Breast Radiotherapy
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	GAIRB2017-127
Approval Date	2017-04-18
Institutional Review Board Name	Institutional Reviwe Board of Gachon University Gil Medical Center
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	KiHoon Sung
Title	MD
Telephone	+82-32-460-8052
Affiliation
Address	21 Namdong-daero 774beon-gil, Namdong-gu, Incheon 21565, Republic of Korea
Contact Person for Public Queries
Name	KiHoon Sung
Title	MD
Telephone	+82-32-460-8052
Affiliation
Address	21 Namdong-daero 774beon-gil, Namdong-gu, Incheon 21565, Republic of Korea
Contact Person for Updating Information
Name	KiHoon Sung
Title	MD
Telephone	+82-32-460-8052
Affiliation
Address	21 Namdong-daero 774beon-gil, Namdong-gu, Incheon 21565, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2017-05-04 Actual
Target Number of Participant	56
Primary Completion Date
Study Completion Date
Name of Study
Recruitment Status	Recruiting
Date of First Enrollment	2017-05-04 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Standard treatment for patients with early stage breast cancer is breast conserving surgery (BCS) followed by radiation therapy (RT). Skin reaction is the most common side-effect of radiotherapy with as many as 95% of patients experiencing some degree of reaction. Various types of topical agents, especially moisturizing cream have been used to prevent and treat skin reaction. Recently, film forming silicone gel has introduced as topical agent for skin reaction. Although the effects of these agents have been well established, there were no studies evaluating the difference of treatment and prevent effect according to type of topical agent. The purpose of this study is to evaluate the impact of film forming silicone gel compared to that of moisturizing cream.

Study Summary Information

Lay Summary

Standard treatment for patients with early stage breast cancer is breast conserving surgery (BCS) followed by radiation therapy (RT). Skin reaction is the most common side-effect of radiotherapy with as many as 95&#37; of patients experiencing some degree of reaction. Various types of topical agents, especially moisturizing cream have been used to prevent and treat skin reaction. Recently, film forming silicone gel has introduced as topical agent for skin reaction. Although the effects of these agents have been well established, there were no studies evaluating the difference of treatment and prevent effect according to type of topical agent. The purpose of this study is to evaluate the impact of film forming silicone gel compared to that of moisturizing cream.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Others (cosmetics)
Intervention Description	To prevent and care supportively the skin reaction after radiotherapy for breast cancer, patients should apply the moisturizer 3 times a day from starting day to 1 month after finishing radiotherapy, according to corresponding study arm.
Number of Arms	2
Arm 1	Arm Label Moisturizer Arm
	Target Number of Participant 28
	Arm Type Active comparator
	Arm Description To prevent and care supportively skin reaction after radiotherapy, patients of moisturizer group should apply the moisturizing cream 3 times a day from starting day to 1 month after finishing radiotherapy.
Arm 2	Arm Label Silicone Gel Arm
	Target Number of Participant 28
	Arm Type Experimental
	Arm Description To prevent and care supportively skin reaction after radiotherapy, patients of silicone gel group should apply the silicone gel 3 times a day from starting day to 1 month after finishing radiotherapy.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C50.99)Malignant neoplasm of breast unspecified, unspecified side
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 20Year~60Year
	Description nonprobability sampling method - convenience sampling a. breast cancer b. patients who were referred to adjuvant radiation therapy c. age with 20 ~ 60 yo d. informed consent should be obtained after understanding of the purpose of this study
Exclusion Criteria	a. former radiation therapy b. skin metastasis c. skin ulceration d. impossible to follow up according to protocol
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	clinical-equivalence
Outcome	erythema (mexameter) & skin hydration (corneometer)
Timepoint	Pre-treatment evaluation followed by 5 times evalutaions with 2 weeks interval
Secondary Outcome(s) 1
Outcome	Questionnaire including skin dryness, itchiness, burning sensation, pain
Timepoint	Pre-treatment evaluation followed by 5 times evalutaions with 2 weeks interval

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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