on-invasive physical plasma in the prevention and treatment of radiation dermatitis in breast cancer irradiation: a phase I-II trial

Phase 1

• Conditions: C50; L58; Radiodermatitis; Malignant neoplasm of breast

• Registration Number: DRKS00026225
• Lead Sponsor: niversitätsklinikum BonnKlinik für Strahlentherapie und Radioonkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-28
• Study Completion: 2023-09-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

whole-breast irradiation (WBI)
- age > 18 years
- breast-conserving surgery for breast cancer
- fractionation regimen of 40.05 Gy in 15 fractions of 2.67 Gy
- oral and written informed consent

Exclusion Criteria

- active smoking
- metastatic disease
- concomitant chemotherapy
- breast reconstruction
- alternative fractionation regimens
- history of ipsilateral breast irradiation
- any preexisting dermatological disorder
- active dermatitis
- current treatment with topical or oral corticosteroids
- patient refusal to participate

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum radiation dermatitis severity as assessed by gradings corresponding to the CTCAE v5.0 criteria and technical skin colour measurements

Secondary Outcome Measures

Name	Time	Method
Patient-reported symptoms (RISRAS)