on-Invasive Physical Plasma for Preventing Radiation Dermatitis in Breast Cancer: A Randomised Double-Blind Placebo-Controlled Trial

Phase 3

Recruiting

Conditions: L58.9
C50.9
Radiodermatitis, unspecified
Breast, unspecified

Registration Number: DRKS00032560

Lead Sponsor: Klinik für Strahlentherapie und Radioonkologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 140

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference in mean clinician-reported radiation dermatitis severity upon radiation treatment completion between both treatment arms (as per CTCAE v5.0)

Secondary Outcome Measures

Name	Time	Method
- patient-reported radiation dermatitis-related symptoms in both treatment arms (as per modified RISRAS questionnaire)<br>- objective radiation dermatitis assessment in both treatment arms (as per reflectance spectrophotometry)<br>- topical corticosteroid prescription rate in both treatment arms<br>- side effects of the intervention in the active treatment arm<br>- trial exit questionnaire designed for this trial