Patients who are eligible to receive adjuvant whole breast radiotherapy with or without regional nodal irradiation as part of their care will be included in this study. Patients will use Silver-plated technology (SPT) dressing as directed per user instruction manual and change dressings weekly. Patients will continue to wear the SPT dressing for 2 weeks following completion of RT. The presence and severity of ARD will be recorded at the time of the weekly OTV and at one month after finishing the treatment.
Adjuvant radiotherapy for breast cancer is standard in the setting of breast conserving therapy. The most common acute toxicity in those receiving breast radiotherapy is acute radiation dermatitis (ARD). This is not only disfiguring, but also painful and uncomfortable. No standard exists for the mitigation or treatment of ARD. Routinely, emollients and steroid based creams, including but not limited to, xeroform gauze, demeboro soaks, triple antibiotic cream, Silvadene, hydrocortisone, and mometasone creams are used. Steroid creams have been shown to change the skin microenvironment and also thin the skin - this is especially concerning as one of the primary goals of BCT is good to excellent cosmetic outcome. Mepitel dressings have been evaluated but are often cumbersome to use and difficult to apply accurately. Silver-plated technology (SPT) dressing, a novel skin dressing, has been shown to have anti-microbial effects thereby reducing the development of ARD. This prospective single arm phase II study will evaluate if SPT dressing reduces the incidence of grade 2 or higher ARD in breast cancer patients who are going to receive adjuvant radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
17
Silver-plated technology (SPT) dressing technology is a wound dressing that has a permanently plated metallic surface, which provides the antimicrobial benefits of silver in the dressing without staining the skin and without increasing bioburden, reducing the development of acute radiation dermatitis (ARD).
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGGrade 2 or greater acute radiation dermatitis (ARD)
Proportion of patients grade 2 or higher acute radiation dermatitis (ARD). ARD is defined as skin changes ranging from faint erythema (reddening) and desquamation (peeling skin) to skin necrosis (death of skin cells) and ulceration, depending on the severity of the reaction that occur in those receiving breast cancer radiation therapy (RT) over 3-4 weeks.
Time frame: At 1 month post RT
Use of advanced skin care products
Proportion of patients receiving breast cancer radiation therapy (RT) over 3-4 weeks using advanced skin care products such as xeroform gauze, triple antibiotic cream, and/or Silvadene.
Time frame: Up to 1 month following completion of RT
Patient satisfaction with silver-plated technology (SPT) dressing
Proportion of patients receiving breast cancer radiation therapy (RT) over 3-4 weeks who are satisfied with SPT dressing as reported on the SPT Dressing Patient Satisfaction Survey. The SPT survey includes SPT individual attributes: Ease of prep and apply, Easy for patient use, Durable for repositioning, Patient Comfort, Wear time of 7 days, Patients overall satisfaction, Caregivers overall satisfaction, by "Satisfaction Levels (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied) It also asks if the "Preferred Product" is the 'New' or 'Previous' product. There are four Yes/No questions also, inquiring as to whether the dressing provides relief when worn, able to be kept on before and after bathing, how many times cream was used to treat ARD, and understanding of directions for use. A scoring metric will be developed to quantify these results and analyze statistically. More 'satisfied' responses would indicate greater overall satisfaction with SPT.
Time frame: At 1 month following completion of RT
Radiation Therapy (RT) Completion with use of silver-plated technology (SPT)
Proportion of patients receiving breast cancer radiation therapy (RT) over 3-4 weeks using SPT dressing who complete RT in comparison to historical controls.
Time frame: At 1 month following completion of RT
Silver-plated technology (SPT) Dressing ARD Visual Evaluation
The SPT Dressing ARD Visual Evaluation Form employs RTOG scoring: 0=No change over Baseline, 1=Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating, 2=Tender or bright erythema, patchy moist desquamation, moderate edema, 3=Confluent moist desquamation other than skin folds, pitting edema, 4=Ulceration, hemorrhage, necrosis. Total scores: 0-24, with higher scores indicating worse ARD.
Time frame: At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month
Radiation-Induced Skin Reaction Assessment Scale (RISRAS)
The Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and Distress Thermometer (DT) is a 31-point scale including 5 patient-reported domains (each scored 0-3) and 4 nurse-reported domains (each scored 0-4). The DT is solely patient-reported (0-10) and also queries specific factors contributing to distress. Patient questions include Tenderness, Discomfort, or Pain, Itch, Burning sensation, Skin reaction interfered with day to day activities, with 0-4 point ratings of "Not at all", "A little", "Quite a bit", "Very much". Nurse questions include presence/grading between 0-100% for Dry desquamation, Moist desquamation, Necrosis and coloring for Erythema between Normal and Deep Purple/Red (abnormal). Total scores: 0-36, with higher scores indicating worse ARD.
Time frame: At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month
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