Dermatitis During Adjuvant Irradiation for BREAst Cancer:

In the randomized DAI-BREAC trial, a reminder app will be prospectively tested that reminds breast cancer patients four times each day to perform the required skin care. This will likely contribute to the reduction of grade ≥2 radiation dermatitis in these patients. A total of 268 patients will be randomized to receive standard skin care supported by a reminder app (Arm A) or standard skin care alone (Arm B). Stratification will be done using the three factors treatment volume, radiation boost, and at least one risk factor of dermatitis. Secondary aims include pain (radiation fields), patient satisfaction with the reminder app (Arm A only), impact of the app on the use of health technology (Arm A only), and benefit from support by staff members of the treating Department of Radiation Oncology and/or the UKSH academy regarding the use of the app (Arm A only).

NCT Number	NCT06483477
Lead Sponsor	University Hospital Schleswig-Holstein Collaborators: University of Southern Denmark, Medical School Hamburg
Conditions	Breast Cancer Female
Enrollment	268 participants
Start Date	2024-12-23
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-01-16