Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiotherapy Side Effect
- Sponsor
- Samsung Medical Center
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Change of cosmesis from baseline
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.
The main question it aims to answer are:
- Changes in breast skin
- Factors related to breast skin changes
- Patient-reported outcomes
- Cosmetic outcomes
Participants will be assessed by multi-dimensional methods before and after radiotherapy:
- Photographs
- Fibrometer
- Questionnaires (BREAST-Q)
- CTCAE version 4.03 evaluated by treating physicians
Investigators
Haeyoung Kim
Associate professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Breast cancer treated with curative surgery
Exclusion Criteria
- •History of thoracic radiation therapy
Outcomes
Primary Outcomes
Change of cosmesis from baseline
Time Frame: 5 year after radiation therapy
Evaluated by two blinded independent physicians based on photographs
Change of patient-reported outcome from baseline
Time Frame: 5 year after radiation therapy
BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Change of fibrosis from baseline
Time Frame: 5 year after radiation therapy
Evaluated using fibrometer measuring both breast
Physician assessed toxicity
Time Frame: 5 year after radiation therapy
CTCAE version 4.03 is used to evaluate physician-assessed toxicities.