Clinical trial · Observational
SMC Radiation Oncology Breast Cancer Cohort Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (24)
- measure
- Change of cosmesis from baseline
- timeFrame
- After 2-3 weeks after the start of radiation therapy (During radiation therapy)
- description
- Evaluated by two blinded independent physicians based on photographs
- measure
- Change of cosmesis from baseline
- timeFrame
- 2-3 weeks after the completion of radiation therapy
- description
- Evaluated by two blinded independent physicians based on photographs
- measure
- Change of cosmesis from baseline
- timeFrame
- 6 months after radiation therapy
- description
- Evaluated by two blinded independent physicians based on photographs
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer treated with curative surgery Exclusion Criteria: * History of thoracic radiation therapy
References
Publications (0)
Data not yet available