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RECRUITING
NCT06483477
NA

Dermatitis During Adjuvant Irradiation for BREAst Cancer:

Sponsor: University Hospital Schleswig-Holstein

View on ClinicalTrials.gov

Summary

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).

Official title: Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade ≥2 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

268

Start Date

2024-12-23

Completion Date

2026-09-30

Last Updated

2025-01-16

Healthy Volunteers

No

Interventions

OTHER

Standard skin care

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.

DEVICE

Reminder App

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.

Locations (5)

Vejle Hospital, University Hospital of Southern Denmark

Vejle, Southern Denmark, Denmark

Medical Practice for Radiotherapy and Radiation Oncology

Hanover, Lower Saxony, Germany

Medical School Hamburg, Schwerin Campus

Schwerin, Mecklenburg-Vorpommern, Germany

Malteser Hospital St. Franziskus

Flensburg, Schleswig-Holstein, Germany

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein

Lübeck, Germany