Clinical trial · Interventional
Dermatitis During Adjuvant Irradiation for BREAst Cancer:
Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade ≥2 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reminder App | Device | — | UNRESOLVED |
| Standard skin care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Standard skin care supported by a reminder app
- interventionNames
- Other: Standard skin care
- Device: Reminder App
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Standard skin care alone
- interventionNames
- Other: Standard skin care
Primary outcomes (1)
- measure
- Prevention of grade ≥2 radiation dermatitis
- timeFrame
- through study completion, an average of 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven invasive breast cancer 2. Indication for adjuvant hypo-fractionated radiotherapy 3. Possession of and ability to use a smartphone 4. Female gender 5. Age ≥18 years 6. Written informed consent 7. Capacity of the patient to contract Exclusion Criteria: 1. Pregnancy, Lactation 2. Expected non-compliance
References
Publications (1)
- DERIVEDRades D, Narvaez-Wolf CA, Dziggel L, Staackmann C, Radtke M, Timke C, Kristiansen C, Duma MN, Yu NY, Janssen S. 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. Trials. 2025 Mar 20;26(1):99. doi: 10.1186/s13063-025-08800-2. PMID 40114285