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The comparative efficacy of Jaungo and non-steroidal moisturizer for dermatitis induced by adjuvant radiation therapy in patients with breast cancer: prospective, randomized controlled, single-blinded, pilot study

Status Approved

First Submitted Date

2021/02/02
Registered Date

2021/03/08
Last Updated Date

2021/03/02

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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	KCT0005971
Unique Protocol ID	HF20C0038_R01
Public/Brief Title	Jaungo vs non-steroidal moisturizer for dermatitis by radiation therapy in patients with breast cancer
Scientific Title	The comparative efficacy of Jaungo and non-steroidal moisturizer for dermatitis induced by adjuvant radiation therapy in patients with breast cancer: prospective, randomized controlled, single-blinded, pilot study
Acronym	자운고엑스덤
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KHNMCOH-2020-12-001-002
Approval Date	2021-01-20
Institutional Review Board Name	Investigational Review Board in Kyung Hee University Hospital at Gangdong
Institutional Review Board Address	892, Dongnam-ro, Gangdong-gu, Seoul
Institutional Review Board Telephone	02-440-8108
Data Monitoring Committee	Yes HelpTrial

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	Seong Woo Yoon
Title	Dr.
Telephone	+82-2-440-7272
Affiliation	Kyung Hee University Oriental Medicine Hospital at Gangdong
Address	Dongnam-ro 892, Gangdong gu, Seoul, Rep. of Korea
Contact Person for Public Queries
Name	Jee Young Lee
Title	Dr.
Telephone	+82-2-440-6210
Affiliation	Kyung Hee University Oriental Medicine Hospital at Gangdong
Address	Dongnam-ro 892, Gangdong gu, Seoul, Rep. of Korea
Contact Person for Updating Information
Name	Jee Young Lee
Title	Dr.
Telephone	+82-2-440-6210
Affiliation	Kyung Hee University Oriental Medicine Hospital at Gangdong
Address	Dongnam-ro 892, Gangdong gu, Seoul, Rep. 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	Not yet recruiting
Date of First Enrollment	2021-03-02 Anticipated
Target Number of Participant	50
Primary Completion Date	2022-12-31 , Anticipated
Study Completion Date	2023-02-28 , Anticipated
Name of Study	Kyung Hee University Hospital at Gangdong
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-03-02 ,

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	Ministry of Health & Welfare
Organization Type	Government
Project ID	HF20C0038

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Patients with breast cancer who enrolled onto the study through screening were randomly assigned to receive either Jaungo or moisturizer. A total of 50 subjects who were scheduled for radiotherapy with a Biological equivalent dose (BED10) of 60 Gy or more after breast conservative surgery were randomly assigned to Jaungo group and the control group, respectively. Jaungo group applies Jaungo 3 times a day for 7 weeks, and the control group applies moisturizer 3 times a day for 7 weeks. The incidence and severity of radiation dermatitis were measured every 1 week from baseline to the end of treatment and 2 weeks after the end of treatment. The single-blinded assessment was performed independently by maintaining the evaluator's blindness. At the end of radiation therapy, RTOG, CSSP, Skindex-29, and VAS for pain are evaluated 2 weeks after the end of radiation therapy.

Study Summary Information

Lay Summary

Patients with breast cancer who enrolled onto the study through screening were randomly assigned to receive either Jaungo or moisturizer. A total of 50 subjects who were scheduled for radiotherapy with a Biological equivalent dose (BED10) of 60 Gy or more after breast conservative surgery were randomly assigned to Jaungo group and the control group, respectively. Jaungo group applies Jaungo 3 times a day for 7 weeks, and the control group applies moisturizer 3 times a day for 7 weeks. The incidence and severity of radiation dermatitis were measured every 1 week from baseline to the end of treatment and 2 weeks after the end of treatment. The single-blinded assessment was performed independently by maintaining the evaluator&#39;s blindness. At the end of radiation therapy, RTOG, CSSP, Skindex-29, and VAS for pain are evaluated 2 weeks after the end of radiation therapy.

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	Prevention
Phase	Phase1/Phase2
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	Jaungo type: ointment dose: 1g frequency: three times a day duration: 7 weeks intervention route: transdermal
Number of Arms	2
Arm 1	Arm Label Jaungo
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description Jaungo type: ointment dose: 1g frequency: three times a day duration: 7 weeks intervention route: transdermal
Arm 2	Arm Label control group
	Target Number of Participant 25
	Arm Type Active comparator
	Arm Description Moisturizer type: cream dose: 1g frequency: three times a day duration: 7 weeks intervention route: transdermal

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C50.99)Malignant neoplasm of breast unspecified, unspecified side Breast cancer
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description • Adulthood participants who are at least 19 years old or older • The subject who were diagnosed with invasive breast cancer and recommended to surgery for breast cancer • The subject who received breast conserving surgery • The subject who were recommended to receive adjuvant radiation therapy after surgery • The Eastern Cooperative Oncology Group (ECOG) performance status 1 or below • The subject who understood the study and voluntarily signed to participate
Exclusion Criteria	• Cancer invasion to skin (T4) • Unhealed scar on the breast • Metastatic stage • The subject who has a history of radiation therapy in thoracic area with any reason • Soft tissue disease • Uncontrolled diabetes mellitus • The subject who are now or planned to be pregnant or breast feeding during the study schedule • The subject who are allergic to the medication • Low compliance with any reason, including communication failure • Abusement of alcohol or medication
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	/Safety/Efficacy
Outcome	RTOG toxicity scale
Timepoint	from visit 0 to visit 9
Secondary Outcome(s) 1
Outcome	Catterall skin scoring profile
Timepoint	visit 1, visit 8 (end of radiation), visit 9 (after 2 weeks of EOR)
Secondary Outcome(s) 2
Outcome	Skindex-29
Timepoint	visit 1, visit 8 (end of radiation), visit 9 (after 2 weeks of EOR)
Secondary Outcome(s) 3
Outcome	Numeric rating scale (NRS)
Timepoint	visit 1, visit 8 (end of radiation), visit 9 (after 2 weeks of EOR)

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	No

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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