Dermatitis During Adjuvant Irradiation for BREAst Cancer:

NCT06483477 | Recruiting

• 1 other identifier: DAI-BREAC
• Study Type: interventional
• Target: 268
• Locations: 2 countries
• Sites: 5

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).

Conditions

Breast Cancer Female

Keywords

Breast cancer; Radiotherapy; Dermatitis; Mobile application

Outcome Measures

Primary Outcomes (1)

• Prevention of grade ≥2 radiation dermatitis

  Radiation dermatitis will be assessed according to CTCAE v5.0.

  through study completion, an average of 4 weeks

Secondary Outcomes (4)

• Pain score

  through study completion, an average of 4 weeks

• Rate of patient satisfaction with the reminder app

  through study completion, an average of 4 weeks

• Degree of the impact of the reminder app

  through study completion, an average of 4 weeks

• Rate of patient satisfaction with support

  through study completion, an average of 4 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Standard skin care supported by a reminder app

Other: Standard skin care; Device: Reminder App

Arm B

ACTIVE COMPARATOR

Standard skin care alone

Other: Standard skin care

Interventions

Standard skin care OTHER

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.

Arm A; Arm B

Reminder App DEVICE

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.

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy, Lactation
• Expected non-compliance

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• University of Southern Denmark: collaborator
• Medical School Hamburg: collaborator

Study Sites (5)

Vejle Hospital, University Hospital of Southern Denmark

Vejle, Southern Denmark, 7100, Denmark

NOT YET RECRUITING

Medical Practice for Radiotherapy and Radiation Oncology

Hanover, Lower Saxony, 30161, Germany

NOT YET RECRUITING

Medical School Hamburg, Schwerin Campus

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

NOT YET RECRUITING

Malteser Hospital St. Franziskus

Flensburg, Schleswig-Holstein, 24939, Germany

NOT YET RECRUITING

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

Lübeck, 23562, Germany

RECRUITING

Related Publications (1)

• Rades D, Narvaez-Wolf CA, Dziggel L, Staackmann C, Radtke M, Timke C, Kristiansen C, Duma MN, Yu NY, Janssen S. Dermatitis during adjuvant irradiation for breast cancer (DAI-BREAC): a randomized controlled trial investigating whether grade >/=2 dermatitis during radiotherapy for breast cancer can be reduced by a mobile application that reminds patients to perform skin care. Trials. 2025 Mar 20;26(1):99. doi: 10.1186/s13063-025-08800-2.

  PMID: 40114285 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Dermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dirk Rades, MD, FASTRO

  Dept. of Radiation Oncology, University of Lubeck, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Rades, MD, FASTRO

CONTACT

0049-451-500; DIRK.RADES@UKSH.DE

Carlos A. Narvaez-Wolf, MD

CONTACT

0049-451-500; Carlos.Narvaez-Wolf@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multinational, randomized, active-controlled, parallel-group, multicenter trial

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); DE (4)