OBJECTIVE, CLINICIAN- AND PATIENT-REPORTED EVALUATION OF LATE TOXICITY FOLLOWING ADJUVANT RADIATION IN EARLY BREAST CANCER: FOLLOW-UP RESULTS OF A RANDOMISED SERIES

• Conditions: C50; L90.5; L81.9; Malignant neoplasm of breast; Scar conditions and fibrosis of skin; Disorder of pigmentation, unspecified

• Registration Number: DRKS00029665
• Lead Sponsor: Klinik für Strahlentherapie und Radioonkologie; Universitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

breast-conserving surgery for breast cancer
- completion of a normofractionated or moderately hypofractionated radiation course without interruptions
- written informed consent

Exclusion Criteria

- double-sided breast cancer (since the contralateral breast is used as an intrapatient control)
- mastectomy
- breast reconstruction with implant
- history of recurrent disease with ipsilateral re-lumpectomy or re-irradiation
- metastatic disease
- any preexisting dermatological disorders
- active dermatitis
- current treatment with topical or oral corticosteroids
- patient refusal to participate

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
skin fibrosis, quantified using ultrasound

Secondary Outcome Measures

Name	Time	Method
late toxicity<br>- clinician-reported outcome measures: Late Effects of Normal Tissue – Subjective, Objective, Management, and Analytic (LENT-SOMA), cosmetic outcome (Harvard Breast Cosmesis Scale)<br>- objective: pigmentation changes (reflectance spectrophotometry)<br>- patient-reported outcome measures: modified Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)