L58.9 C50.9
Conditions
Interventions
Group 1: 5% urea-based lotion twice daily to the whole breast + 120 seconds of topical non-invasive physical plasma to the whole breast, daily during radiation treatment
Group 2: 5% urea-based lotion
Sponsors
Klinik für Strahlentherapie und Radioonkologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: subjects will only be included in the study if they meet all of the following criteria: - age = 18 years (no upper limit) - breast-conserving surgery for breast cancer or carcinoma in situ (C50.9) - whole-breast irradiation - moderately hypofractionated radiation regimen, with or without a boost to the tumour bed (simultaneous-integrated or sequential) - oral and written informed consent
Exclusion criteria
Exclusion criteria: subjects will not be included in the study if any of the following criteria apply: - synchronous metastatic disease - mastectomy - reconstruction with breast implant - impaired surgical wound healing at the time of radiation treatment initiation - alternative fractionation regimens - history of ipsilateral breast irradiation - any pre-existing dermatological disorder - active dermatitis - current treatment with topical or oral corticosteroids - patient refusal to participate - subjects without legal capacity to understand the nature, scope, significance, or consequences of a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| difference in mean clinician-reported radiation dermatitis severity upon radiation treatment completion between both treatment arms (as per CTCAE v5.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| - patient-reported radiation dermatitis-related symptoms in both treatment arms (as per modified RISRAS questionnaire) - objective radiation dermatitis assessment in both treatment arms (as per reflectance spectrophotometry) - topical corticosteroid prescription rate in both treatment arms - side effects of the intervention in the active treatment arm - trial exit questionnaire designed for this trial | — |
Countries
Germany
Contacts
Public ContactCas Dejonckheere
Klinik für Strahlentherapie und Radioonkologie
Outcome results
None listed