Silverlon to Reduce Radiation Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to see if a silver-nylon dressing (Silverlon®, Argentum Medical) is useful for the prevention or treatment of radiation dermatitis in patients receiving radiation therapy to the breast.

Official Title
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An Unblinded, Open-label Study Evaluating the Safety of Silverlon to Manage Radiation Dermatitis.

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Device: Silverlon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females, 22 years of age or older, with diagnosis of primary breast cancer (excluding inflammatory and medullary breast cancers). Scheduled to receive short-course external beam radiation therapy (i.e., 2.0-3.0 Gy for 15-20 fractions) or conventional external beam radiation therapy (i.e., 1.8-2.0 Gy for 25-40 fractions), with or without boost dose, to the whole breast. Not receiving concurrent chemotherapy. Subject may have had chemotherapy prior to radiation. A minimum of two weeks is required between the end of chemotherapy and start of radiation therapy. No history of previous breast or chest radiation therapy. Subject may or may not have had surgery (lumpectomy or mastectomy) prior to RT. (Note: Surgery is not required for eligibility). Subjects may be currently prescribed hormone treatment or Herceptin therapy. Subjects must be able to read, speak, and understand English language (all study forms are in English). Subjects must be able to give informed consent. Subjects must be willing to have photographs taken of radiation-induced skin changes in the radiation treatment area. Subjects must be willing to wear Silverlon dressing and undergarment (i.e., bra) at all times, except when bathing/showering and during their radiation therapy session. Subjects must be willing to complete a Silverlon Compliance Log to document the date and time that Silverlon was removed and applied each day during the study. Exclusion Criteria: Diagnosis of medullary or inflammatory breast cancer. Diagnosis of tumors of the breast other than primary breast cancer (skin cancers, lymphomas, or metastatic cancers from other primary sites). Partial breast irradiation (PBI) treatment technique is not eligible. Concurrent chemotherapy. Pregnant or planning to become pregnant. Pregnant females are ineligible because pregnancy is a contraindication for RT. All subjects of childbearing potential will be asked if they are pregnant or could be pregnant. The subject must respond no to continue with radiation and to participate in this clinical study. Previous radiation to the chest or breast. Radiation being given for palliative purposes. Presence of unhealed surgical wounds, biopsy sites, open wounds in the breast or chest area. Presence of breast infection. Subjects currently on anti-EGFR (human epidermal growth factor receptor) therapy, such as Iressa (gefitinib) or Erbitux (cetuximab, C225). Previous diagnosis of autoimmune disease, connective tissue disease, or radiosensitivity disorder. Presence of any active dermatological issues in radiation treatment area (i.e., fungal skin infection, dermatitis, psoriasis plaques, etc). Chronic skin disease of the breast, previous breast trauma or scarring of the breast Subjects with known sensitivity to silver or nylon. Subjects unable or unwilling to wear Silverlon dressings and undergarment (i.e., bra) at all times, except while bathing/showering and during their radiation therapy session. Subjects unable to speak, read, or understand English language (all study forms are in English).

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Silverlon dressing
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silverlon arm<br> | Device: Silverlon<br>* silver nylon dressing will be applied daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an adverse skin event |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean radiation therapy oncology group toxicity score | The radiation oncologist or nurse will rate the skin reaction in the area where Silverlon dressing was applied using the RTOG scale which ranges from 0-5 with higher scores indicating worse outcome. | 12 weeks | 
| mean radiation induced skin reaction assessment scale | This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale individually scores the extent and severity of erythema, dry desquamation, moist desquamation, and necrosis using a 5-point scale from 0 to 4. Erythema is rated based on the degree of color change. Dry desquamation, moist desquamation, and necrosis are rated based on the percentage of the treatment area affected by that particular reaction. The patient component focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The higher the score, the worse the skin reaction. | 12 weeks |