Silverlon to Reduce Radiation Dermatitis

NCT04238728 | Completed Phase 1 Results FDA Device

• 1 other identifier: 00004587
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With an Adverse Skin Event

  12 weeks

Secondary Outcomes (4)

• Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score

  2 weeks

• Mean Radiation Induced Skin Reaction Assessment Scale

  Mid study-visit, approximately 2 weeks

• Mean Radiation Induced Skin Reaction Assessment Scale

  End of radiation therapy, approximately 4.5 weeks

• Mean Radiation Induced Skin Reaction Assessment Scale

  2 weeks post radiation therapy, approximately 6.5 weeks

Study Arms (1)

Silverlon arm

EXPERIMENTAL

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.

Device: Silverlon

Interventions

Silverlon DEVICE

silver nylon dressing will be applied daily

Silverlon arm

Eligibility Criteria

• Age: 22 Years+
• Gender Eligibility Details: Subjects must be female. Approximately 99% of breast cancer diagnoses occur in adult women. Since too few men are diagnosed with the disease to allow meaningful sub-group analyses, subject accrual will only be women (≥ 18 years of age) with breast cancer. Additionally, men are unlikely to wear a bra and the dressing would have to be held in place using another method, which is not the purpose of this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Results Point of Contact

• Title: Julie Ryan, MD
• Organization: University of Rochester Medical Center

Julie_Ryan@URMC.Rochester.edu

585-276-3862

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Silverlon dressing

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 23, 2020
• Study Start: August 31, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 25, 2022
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)