Clinical trial NCT06831084: Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology
Official title: Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology: A Single Arm Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Dermatitis Acute
Keywords: acute radiation dermatitis (ARD)
Silver-plated technology (SPT) dressing
adjuvant radiotherapy (RT)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Bravida Medical
First posted: 2025-02-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: Adjuvant radiotherapy for breast cancer is standard in the setting of breast conserving therapy. The most common acute toxicity in those receiving breast radiotherapy is acute radiation dermatitis (ARD). This is not only disfiguring, but also painful and uncomfortable. No standard exists for the mitigation or treatment of ARD. Routinely, emollients and steroid based creams, including but not limited to, xeroform gauze, demeboro soaks, triple antibiotic cream, Silvadene, hydrocortisone, and mometasone creams are used. Steroid creams have been shown to change the skin microenvironment and also thin the skin - this is especially concerning as one of the primary goals of BCT is good to excellent cosmetic outcome. Mepitel dressings have been evaluated but are often cumbersome to use and difficult to apply accurately. Silver-plated technology (SPT) dressing, a novel skin dressing, has been shown to have anti-microbial effects thereby reducing the development of ARD. This prospective single arm phase II study will evaluate if SPT dressing reduces the incidence of grade 2 or higher ARD in breast cancer patients who are going to receive adjuvant radiotherapy.

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.

Primary outcomes:
measure: Grade 2 or greater acute radiation dermatitis (ARD)
timeFrame: At 1 month post RT
Secondary outcomes:
measure: Use of advanced skin care products
timeFrame: Up to 1 month following completion of RT
measure: Patient satisfaction with silver-plated technology (SPT) dressing
timeFrame: At 1 month following completion of RT
measure: Radiation Therapy (RT) Completion with use of silver-plated technology (SPT)
timeFrame: At 1 month following completion of RT
measure: Silver-plated technology (SPT) Dressing ARD Visual Evaluation
timeFrame: At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month
measure: Radiation-Induced Skin Reaction Assessment Scale (RISRAS)
timeFrame: At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: UPMC Magee-Womens Hospital
name: Parul N Barry, MD
role: PRINCIPAL_INVESTIGATOR
References: