Clinical trial · Interventional
Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology
Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology: A Single Arm Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Dermatitis Acute | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Silver plated technology (SPT) dressing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Silver-Plated Technology dressing
- description
- SPT dressing (Silverlon) worn for at least for 18 hours a day (removed while showering, bathing, and while having radiation therapy)
- interventionNames
- Device: Silver plated technology (SPT) dressing
Primary outcomes (1)
- measure
- Grade 2 or greater acute radiation dermatitis (ARD)
- timeFrame
- At 1 month post RT
- description
- Proportion of patients grade 2 or higher acute radiation dermatitis (ARD). ARD is defined as skin changes ranging from faint erythema (reddening) and desquamation (peeling skin) to skin necrosis (death of skin cells) and ulceration, depending on the severity of the reaction that occur in those receiving breast cancer radiation therapy (RT) over 3-4 weeks.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available