Clinical trial NCT04238728: Silverlon to Reduce Radiation Dermatitis
Official title: An Unblinded, Open-label Study Evaluating the Safety of Silverlon to Manage Radiation Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Radiation Dermatitis
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2020-01-23
Enrollment: 31
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Silverlon dressing
Primary purpose: SUPPORTIVE_CARE

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.


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).

Primary outcomes:
measure: Number of Participants With an Adverse Skin Event
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score
timeFrame: 2 weeks
measure: Mean Radiation Induced Skin Reaction Assessment Scale
timeFrame: Mid study-visit, approximately 2 weeks
measure: Mean Radiation Induced Skin Reaction Assessment Scale
timeFrame: End of radiation therapy, approximately 4.5 weeks
measure: Mean Radiation Induced Skin Reaction Assessment Scale
timeFrame: 2 weeks post radiation therapy, approximately 6.5 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Wilmot Cancer Institute
state: New York
Study officials:
References: