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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029665

Enrollment

100

Registered

2022-07-19

Start date

2022-09-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50 L90.5 L81.9

Interventions

Group 1: normofractionation Group 2: hypofractionation

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
skin fibrosis, quantified using ultrasound	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactCas Dejonckheere

Strahlentherapie und RadioonkologieUniversitätsklinikum Bonn

cas.dejonckheere@ukbonn.de0151 18853378

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 8, 2026