Actively Recruiting
Dermatitis During Adjuvant Irradiation for BREAst Cancer:
Led by University Hospital Schleswig-Holstein · Updated on 2025-01-16
268
Participants Needed
5
Research Sites
92 weeks
Total Duration
On this page
Sponsors
U
University Hospital Schleswig-Holstein
Lead Sponsor
U
University of Southern Denmark
Collaborating Sponsor
AI-Summary
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).
CONDITIONS
Official Title
Dermatitis During Adjuvant Irradiation for BREAst Cancer:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven invasive breast cancer
- Indication for adjuvant hypo-fractionated radiotherapy
- Possession of and ability to use a smartphone
- Female gender
- Age 18 years or older
- Written informed consent
- Capacity to provide consent
You will not qualify if you...
- Pregnancy or lactation
- Expected non-compliance
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Vejle Hospital, University Hospital of Southern Denmark
Vejle, Southern Denmark, Denmark, 7100
Not Yet Recruiting
2
Medical Practice for Radiotherapy and Radiation Oncology
Hanover, Lower Saxony, Germany, 30161
Not Yet Recruiting
3
Medical School Hamburg, Schwerin Campus
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Not Yet Recruiting
4
Malteser Hospital St. Franziskus
Flensburg, Schleswig-Holstein, Germany, 24939
Not Yet Recruiting
5
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
Lübeck, Germany, 23562
Actively Recruiting
Research Team
D
Dirk Rades, MD, FASTRO
CONTACT
C
Carlos A. Narvaez-Wolf, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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