Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of… (NCT06831084) | Clinical Trial Compass
CompletedNot Applicable
Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology
United States17 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Prior RT to the breast +/- regional lymph nodes or prior RT to the chest wall and regional lymph nodes.
✕. Contraindication to the application of SPT dressing (e.g. allergy).
✕. Pregnancy/lactation or women of childbearing potential who are unable or unwilling to use adequate contraception during RT.
✕. Planned RT course \>4 weeks or \<3 weeks.
What they're measuring
1
Grade 2 or greater acute radiation dermatitis (ARD)
. Active connective tissue disorders/collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash in the area that will receive RT, systemic lupus erythematosis, or scleroderma.
✕. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
✕. Known sensitivity or allergy to silver or nylon.