Dermatitis During Adjuvant Irradiation for BREAst Cancer:

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital Schleswig-Holstein

About this trial

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).

Eligibility criteria

Qualifiers

Histologically proven invasive breast cancer

Indication for adjuvant hypo-fractionated radiotherapy

Possession of and ability to use a smartphone

Female gender

Disqualifiers

Pregnancy, Lactation

Expected non-compliance

Trial design

Treatments tested in this trial

  • Standard skin care
  • Reminder App

Treatment groups

268 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital Schleswig-Holstein

Lead sponsor

University of Southern Denmark

Collaborator

Medical School Hamburg

Collaborator