Dermatitis during adjuvant irradiation for breast cancer (DAI-BREAC): a randomized controlled trial investigating whether grade ≥2 dermatitis during radiotherapy for breast cancer can be reduced by a mobile application that reminds patients to perform skin care.

BACKGROUND: Radiotherapy of breast cancer can be associated with dermatitis. Grade ≥2 radiation dermatitis can be painful and impair the patients' quality of life. To reduce the risk of this complication, patients have to perform skin care several times each day. This may require a considerable level of compliance. This randomized DAI-BREAC trial investigates whether a mobile application reminding the patients four times per day to perform skin care (reminder app) will contribute to reduction of grade ≥2 radiation dermatitis.

METHODS: This multinational, randomized, active-controlled, parallel-group, multicenter trial compares standard skin care supported by a reminder app (Arm A) versus standard skin care alone (Arm B) regarding grade ≥2 radiation dermatitis in patients receiving adjuvant radiotherapy for breast cancer. The effect of the app will be considered clinically relevant, if the rate of grade ≥2 radiation dermatitis is reduced from 25.4% (rate identified in a preceding study) to 15%. A total of 134 patients per arm including drop-outs are required. Secondary aims include pain (visual analogue scale), patient satisfaction with the app (questionnaire), impact of the app on the use of health technology (questionnaire), and benefit from support (coaching) by staff members regarding the use of the app (questionnaire).

DISCUSSION: If the reminder app contributes to a decrease of grade ≥2 radiation dermatitis in patients irradiated for breast cancer, it will likely become a useful instrument for these patients.

TRIAL REGISTRATION: Clinicaltrials.gov (NCT06483477; URL: https://clinicaltrials.gov/show/NCT06483477 ). Registered on 1st of July, 2024. First patient was included in December 2024.