ArticleTrials2025
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.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06483477 (Dermatitis During Adjuvant Irradiation for BREAst Cancer), which is not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade ≥2 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)
Who cites it
1 citing paper in PubMed.
- Usability of a Reminder App that May Help to Reduce Radiotherapy-related Skin Toxicity in Patients With Breast Cancer.In vivo (Athens, Greece)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundRadiotherapy 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.
methodsThis 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 registrationClinicaltrials.gov (NCT06483477; URL: https://clinicaltrials.gov/show/NCT06483477 ). Registered on 1st of July, 2024. First patient was included in December 2024.
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