Dermatitis During Adjuvant Irradiation for BREAst Cancer:

NARecruitingINTERVENTIONAL
Enrollment

268

Participants

Timeline

Start Date

December 23, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Breast Cancer Female
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.

Trial Locations (5)

7100

NOT_YET_RECRUITING

Vejle Hospital, University Hospital of Southern Denmark, Vejle

19055

NOT_YET_RECRUITING

Medical School Hamburg, Schwerin Campus, Schwerin

23562

RECRUITING

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

24939

NOT_YET_RECRUITING

Malteser Hospital St. Franziskus, Flensburg

30161

NOT_YET_RECRUITING

Medical Practice for Radiotherapy and Radiation Oncology, Hanover

All Listed Sponsors
collaborator

University of Southern Denmark

OTHER

collaborator

Medical School Hamburg

OTHER

lead

University Hospital Schleswig-Holstein

OTHER