Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040983
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-18
First Post:
2023-09-01
Brief Title:
Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Monocenter Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer is the top one incidence of cancer in women Whole breast radiation therapy plays an indispensable role in the course of breast cancer treatment and the radiation dermatitis is the major side effect affected quality of life Radiation dermatitis can be divided into acute and chronic Severe acute radiation dermatitis affects the quality of life of patients during the course of treatment and may cause treatment interruption and affect the efficacy Chronic radiation dermatitis may cause irreversible skin problems and lead to so-called radiation-irritated skin radiation-irritated skin seriously affects the quality of life of breast cancer patients after treatment
This study will enroll 30 breast cancer patients who received whole breast radiation therapy after breast conserving surgery Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days taking care of avoiding applications from 1 to 4 h before treatment to prevent Build-up effect
Subjects will need to come back to clinics for assessment weekly during radiotherapy 2 weeks after radiotherapy and 6 weeks after radiotherapy The evaluation includes physical examinations questionnaire surveys skin observation and measurements and photographs The total study time is at least 3 months The target area of radiation-irritated skin condition will be observed and graded according to CTCAE rate The skin physiological parameters will be detected by MoistureMeter SC Vapometer SkinColorCatch and HX-YL001 infrared thermometer
Statistical analysis of skin physiological parameters is used to evaluate the efficacy of FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy
This study will enroll 30 breast cancer patients who received whole breast radiation therapy after breast conserving surgery Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days taking care of avoiding applications from 1 to 4 h before treatment to prevent Build-up effect
Subjects will need to come back to clinics for assessment weekly during radiotherapy 2 weeks after radiotherapy and 6 weeks after radiotherapy The evaluation includes physical examinations questionnaire surveys skin observation and measurements and photographs The total study time is at least 3 months The target area of radiation-irritated skin condition will be observed and graded according to CTCAE rate The skin physiological parameters will be detected by MoistureMeter SC Vapometer SkinColorCatch and HX-YL001 infrared thermometer
Statistical analysis of skin physiological parameters is used to evaluate the efficacy of FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None