Dermatitis During Adjuvant Irradiation for BREAst Cancer:

ConditionBreast Cancer Female

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Standard skin care
Other intervention
From the start of radiotherapy, standard skin care has to be performed by the patient. This may vary at the participating centers. At the site in Lübeck, it includes fatty cream with 2-10% urea (fatty cream alone, if patients do not tolerate urea) and, in case of pruritus, addition of mometasone furoate cream. In case of grade ≥2 moist desquamation or grade ≥3 radiation dermatitis, each day antiseptic agents will be administered for wound cleansing followed by administration of silicon or calcium alginate bandage. This treatment will be continued until moist desquamation radiation disappears and radiation dermatitis improves to grade 2. Fatty cream with 2-10% urea is applied to the irradiated skin four times daily. Mometasone furoate cream: In addition to the fatty cream with 2-10% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.
Reminder App
Device
In addition to standard skin care, patients are supported by a Reminder App. The purpose of the app is to remind the patients in an intuitive, unobtrusive and supportive way to perform skin care. By default, patients are reminded four times a day, but they will also be able to define a notification schedule that best suits their personal needs. The patients may postpone each required care procedure for up to 2 hours. With each procedure, the patients are guided through the skin care with simple and self-explanatory illustrations. To increase the patients' motivation, they will additionally earn points for regular and punctual performed care procedures. The patients receive a hand-out including instructions how to properly perform skin care, but they can also find an information page within the application that includes similar instructions.

Treatment groups

268 Participants

are divided into 2 treatment groups

Group A: Arm AExperimental treatment 2 interventions

Group B: Arm BActive comparator 1 intervention

Trial outcomes