SMC Radiation Oncology Breast Cancer Cohort Study

Recruiting

• Conditions: Radiotherapy Side Effect

• Registration Number: NCT05775757
• Lead Sponsor: Samsung Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Breast cancer treated with curative surgery

Exclusion Criteria

• History of thoracic radiation therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of cosmesis from baseline	5 year after radiation therapy	Evaluated by two blinded independent physicians based on photographs
Change of patient-reported outcome from baseline	5 year after radiation therapy	BREAST-Q questionnaire is used to evaluate patient-reported outcome.
Change of fibrosis from baseline	5 year after radiation therapy	Evaluated using fibrometer measuring both breast
Physician assessed toxicity	5 year after radiation therapy	CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of