Back to resultsSilverlon to Reduce Radiation Dermatitis
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Silverlon
Sponsored by
About this trial
This is an interventional supportive care trial for Radiation Dermatitis
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).
Sites / Locations
- Wilmot Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Silverlon arm
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with an adverse skin event
Secondary Outcome Measures
mean radiation therapy oncology group 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.
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 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 patient component focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The higher the score, the worse the skin reaction.
Full Information
NCT ID
NCT04238728
First Posted
January 16, 2020
Last Updated
March 28, 2022
Sponsor
University of Rochester
Collaborators
Biomedical Advanced Research and Development Authority
1. Study Identification
Unique Protocol Identification Number
NCT04238728
Brief Title
Silverlon to Reduce Radiation Dermatitis
Official Title
An Unblinded, Open-label Study Evaluating the Safety of Silverlon to Manage Radiation Dermatitis.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Biomedical Advanced Research and Development Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Silverlon dressing
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silverlon arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Silverlon
Intervention Description
silver nylon dressing will be applied daily
Primary Outcome Measure Information:
Title
Number of participants with an adverse skin event
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
mean radiation therapy oncology group toxicity score
Description
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.
Time Frame
12 weeks
Title
mean radiation induced skin reaction assessment scale
Description
This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale 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 patient component focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The higher the score, the worse the skin reaction.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Wilmot Cancer Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data will be shared if requested.
Learn more about this trial
Silverlon to Reduce Radiation Dermatitis
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