Silverlon to Reduce Radiation Dermatitis

Phase 1

Completed

Conditions: Radiation Dermatitis

Interventions: Device: Silverlon

Registration Number: NCT04238728

Lead Sponsor: University of Rochester

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 31

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silverlon arm	Silverlon	Silverlon is a silver-nylon dressing approved for treatment of burns and wounds. In this study, the Silverlon dressing will be applied to the whole breast area receiving radiation therapy throughout the prescribed course of radiation therapy starting the first day of radiation therapy and until two weeks post-radiation. The Silverlon dressing will be held in place by a bra and worn daily except when bathing/showering, received radiation therapy, or swimming. Subject document when they remove the dressing and apply the dressing every day.

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Adverse Skin Event	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score	2 weeks	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. Grade 0 No change; Normal Skin Grade 1 Faint erythema; dry desquamation; epilation, decreased sweating Grade 2 Tender or bright erythema; moderate edema; patchy moist desquamation only in skin folds. Grade 3 Confluent moist desquamation in areas other than skin folds; pitting edema Grade 4 Ulceration; hemorrhage; necrosis
Mean Radiation Induced Skin Reaction Assessment Scale	2 weeks post radiation therapy, approximately 6.5 weeks	This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale (HPAS) 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 HPAS score can range between 0 to 16. The patient symptom scale focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The patient symptom scale can range between 4 to 16. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The total skin reaction score can range between 4 to 32. The higher the score, the worse the skin reaction.