Silverlon to Reduce Radiation Dermatitis
Condition: Radiation Dermatitis
MeSH terms: Dermatitis; Radiodermatitis
Intervention: Silverlon
Intervention description: silver nylon dressing will be applied daily
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Intervention model description: Silverlon dressing
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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).