NCT06483477 Dermatitis During Adjuvant Irradiation for BREAst Cancer:
| NCT ID | NCT06483477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Schleswig-Holstein |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 268 participants |
| Start Date | 2024-12-23 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 268 participants in total. It began in 2024-12-23 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Histologically proven invasive breast cancer 2. Indication for adjuvant hypo-fractionated radiotherapy 3. Possession of and ability to use a smartphone 4. Female gender 5. Age ≥18 years 6. Written informed consent 7. Capacity of the patient to contract Exclusion Criteria: 1. Pregnancy, Lactation 2. Expected non-compliance
Contact & Investigator
Dirk Rades, MD, FASTRO
PRINCIPAL INVESTIGATOR
Dept. of Radiation Oncology, University of Lubeck, Germany
Frequently Asked Questions
Who can join the NCT06483477 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06483477 currently recruiting?
Yes, NCT06483477 is actively recruiting participants. Contact the research team at DIRK.RADES@UKSH.DE for enrollment information.
Where is the NCT06483477 trial being conducted?
This trial is being conducted at Vejle, Denmark, Hanover, Germany, Schwerin, Germany, Flensburg, Germany and 1 additional location.
Who is sponsoring the NCT06483477 clinical trial?
NCT06483477 is sponsored by University Hospital Schleswig-Holstein. The principal investigator is Dirk Rades, MD, FASTRO at Dept. of Radiation Oncology, University of Lubeck, Germany. The trial plans to enroll 268 participants.
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