Silverlon to Reduce Radiation Dermatitis

Radiation Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238728
• Other study ID #: 00004587
• Status: Completed
• Phase: Phase 1
• Start date: August 31, 2020
• Est. completion date: March 25, 2022

Study information

• Verified date: March 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 25, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Device:
• Silverlon
silver nylon dressing will be applied daily

Locations

Country	Name	City	State
United States	Wilmot Cancer Institute	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Adverse Skin Event		12 weeks
Secondary	Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) 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.; 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	2 weeks
Secondary	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 (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.	Mid study-visit, approximately 2 weeks
Secondary	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 (HAPS) 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.	End of radiation therapy, approximately 4.5 weeks
Secondary	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 (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.	2 weeks post radiation therapy, approximately 6.5 weeks