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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silverlon | Device | silver nylon dressing will be applied daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Skin Event | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmot Cancer Institute | Rochester | New York | 14642 | United States |
De-identified participant data will be shared if requested.
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111 patient screened. 41 were ineligible. 31 were not approached because they already started radiation therapy or were undergoing chemotherapy or surgery. 39 were approached. 1 screen failed and 31 consented and started the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silverlon Arm | Silverlon: silver nylon dressing will be applied daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Silverlon Arm | Silverlon: silver nylon dressing will be applied daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With an Adverse Skin Event | Posted | Count of Participants | Participants | 12 weeks |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silverlon Arm | Silverlon: silver nylon dressing will be applied daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| open area in inframammary fold | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Ryan, MD | University of Rochester Medical Center | 585-276-3862 | Julie_Ryan@URMC.Rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2021 | Mar 21, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2021 | Jan 17, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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Silverlon dressing
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| 2 weeks |
| 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 |
| 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 |
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 30 patients completed the 2 week timepoint of the study. | Posted | Count of Participants | Participants | 2 weeks |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Mid study-visit, approximately 2 weeks |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | End of radiation therapy, approximately 4.5 weeks |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 weeks post radiation therapy, approximately 6.5 weeks |
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| 31 |
| 1 |
| 31 |
| 0 |
| 31 |
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| D014947 |
| Wounds and Injuries |
| Title | Measurements |
|---|
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| Grade 3 |
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| Grade 4 |
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