Silverlon to Reduce Radiation Dermatitis

NCT ID: NCT04238728

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2022-03-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Silverlon arm

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.

Group Type: EXPERIMENTAL

Silverlon

Intervention Type: DEVICE

silver nylon dressing will be applied daily

Interventions

Silverlon

silver nylon dressing will be applied daily

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 22 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Julie Ryan Wolf

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wilmot Cancer Institute

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00004587

Identifier Type: -

Identifier Source: org_study_id