Radiation Dermatitis
Conditions
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.
Interventions
DEVICESilverlon
silver nylon dressing will be applied daily
Sponsors
Biomedical Advanced Research and Development Authority
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Silverlon dressing
Eligibility
Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With an Adverse Skin Event | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score | 2 weeks | 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 |
| Mean Radiation Induced Skin Reaction Assessment Scale | Mid study-visit, approximately 2 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Silverlon Arm Silverlon: silver nylon dressing will be applied daily | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Silverlon Arm |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
Primary
Number of Participants With an Adverse Skin Event
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silverlon Arm | Number of Participants With an Adverse Skin Event | 1 Participants |
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.
Time frame: Mid study-visit, approximately 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silverlon Arm | Mean Radiation Induced Skin Reaction Assessment Scale | 6.31 score on a scale |
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.
Time frame: End of radiation therapy, approximately 4.5 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silverlon Arm | Mean Radiation Induced Skin Reaction Assessment Scale | 10.77 score on a scale |
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.
Time frame: 2 weeks post radiation therapy, approximately 6.5 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silverlon Arm | Mean Radiation Induced Skin Reaction Assessment Scale | 8.63 score on a scale |
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
Time frame: 2 weeks
Population: 30 patients completed the 2 week timepoint of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Silverlon Arm | Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score | Grade 0 | 1 Participants |
| Silverlon Arm | Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score | Grade 1 | 20 Participants |
| Silverlon Arm | Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score | Grade 2 | 9 Participants |
| Silverlon Arm | Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score | Grade 3 | 0 Participants |
| Silverlon Arm | Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score | Grade 4 | 0 Participants |