Using silver-plated dressings to reduce skin damage from breast cancer radiotherapy

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

This study is testing if silver-plated dressings can help reduce skin damage in breast cancer patients receiving radiation treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 17 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT06831084 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of silver-plated technology (SPT) dressings in reducing acute radiation dermatitis (ARD) in breast cancer patients undergoing adjuvant radiotherapy. Eligible patients will apply the SPT dressing weekly during their treatment and for two weeks afterward, while the severity of ARD will be monitored through regular assessments. The study aims to determine if SPT dressings can lower the incidence of moderate to severe ARD compared to standard care practices. This approach seeks to improve patient comfort and cosmetic outcomes following breast cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are male or female breast cancer patients scheduled for adjuvant radiotherapy at Magee Women's Hospital.

Not a fit: Patients who have previously received radiotherapy to the breast or chest area will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of painful and disfiguring skin reactions in breast cancer patients receiving radiotherapy.

How similar studies have performed: While the use of silver-plated dressings is a novel approach, previous studies have shown promise in using similar antimicrobial technologies for skin care in radiation therapy.

Eligibility criteria

Inclusion Criteria:

1. ECOG ≤ 2
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.
3. Patients who will receive all of their RT at Magee Women's Hospital.
4. Agreeable to use of SPT dressing as directed (changing once weekly during RT and the additional 2 weeks following completion of RT).
5. Agreeable that any normal or physician recommended skin care regimen is to be used 1 hour prior to use of SPT dressing.
6. Agreeable to completion of assessments and skin checks and in person follow up at about 1 month following completion of RT.
7. Must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Prior RT to the breast +/- regional lymph nodes or prior RT to the chest wall and regional lymph nodes.
2. Contraindication to the application of SPT dressing (e.g. allergy).
3. Pregnancy/lactation or women of childbearing potential who are unable or unwilling to use adequate contraception during RT.
4. Planned RT course \>4 weeks or \<3 weeks.
5. 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.
6. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
7. Known sensitivity or allergy to silver or nylon.

Where this trial is running

Pittsburgh, Pennsylvania

• UPMC Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Parul N Barry, MD — UPMC Magee-Womens Hospital
• Study coordinator: Samantha Demko, RN

Conditions Radiation Dermatitis Acute; acute radiation dermatitis; Silver-plated technology dressing; adjuvant radiotherapy