Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology: A Single Arm Phase II Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Patients who are eligible to receive adjuvant whole breast radiotherapy with or without regional nodal irradiation as part of their care will be included in this study. Patients will use Silver-plated technology (SPT) dressing as directed per user instruction manual and change dressings weekly. Patients will continue to wear the SPT dressing for 2 weeks following completion of RT. The presence and severity of ARD will be recorded at the time of the weekly OTV and at one month after finishing the treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ECOG ≤ 2

• Male or female patients with breast cancer or breast carcinoma in situ who are recommended to receive adjuvant radiotherapy to the breast +/- regional lymph nodes or are planned to receive adjuvant radiotherapy to the chest wall and regional lymph nodes over 3 to 4 weeks.

• Patients who will receive all of their RT at Magee Women's Hospital.

• Agreeable to use of SPT dressing as directed (changing once weekly during RT and the additional 2 weeks following completion of RT).

• Agreeable that any normal or physician recommended skin care regimen is to be used 1 hour prior to use of SPT dressing.

• Agreeable to completion of assessments and skin checks and in person follow up at about 1 month following completion of RT.

• Must have the ability to understand and the willingness to sign a written informed consent document.

Locations
United States
Pennsylvania
UPMC Magee-Womens Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Samantha Demko, RN
albesl@upmc.edu
4126231400
Backup
Brieanna Marino, MS
rowlesbm@upmc.edu
4126478258
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 17
Treatments
Experimental: Silver-Plated Technology dressing
SPT dressing (Silverlon) worn for at least for 18 hours a day (removed while showering, bathing, and while having radiation therapy)
Related Therapeutic Areas
Sponsors
Collaborators: Bravida Medical
Leads: Parul Barry

This content was sourced from clinicaltrials.gov