Dermatitis During Adjuvant Irradiation for BREAst Cancer:
Recruiting · NCT06483477 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Schleswig-Holstein
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- Histologically proven invasive breast cancer
- Indication for adjuvant hypo-fractionated radiotherapy
- Possession of and ability to use a smartphone
- Female gender
- Age ≥18 years
- Written informed consent
- Capacity of the patient to contract
Exclusion criteria
- Pregnancy, Lactation
- Expected non-compliance
Where it is running
5 locations listed.
- Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein - Lübeck, Germany
- 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
- Vejle Hospital, University Hospital of Southern Denmark - Vejle, Southern Denmark, Denmark