Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology: A Single Arm Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Grade 2 or greater acute radiation dermatitis (ARD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with breast cancer or breast carcinoma in situ who are recommended to receive adjuvant radiotherapy to the breast +/- regional lymph nodes or are planned to receive adjuvant radiotherapy to the chest wall and regional lymph nodes over 3 to 4 weeks.
- •Patients who will receive all of their RT at Magee Women's Hospital.
- •Agreeable to use of SPT dressing as directed (changing once weekly during RT and the additional 2 weeks following completion of RT).
- •Agreeable that any normal or physician recommended skin care regimen is to be used 1 hour prior to use of SPT dressing.
- •Agreeable to completion of assessments and skin checks and in person follow up at about 1 month following completion of RT.
- •Must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Prior RT to the breast +/- regional lymph nodes or prior RT to the chest wall and regional lymph nodes.
- •Contraindication to the application of SPT dressing (e.g. allergy).
- •Pregnancy/lactation or women of childbearing potential who are unable or unwilling to use adequate contraception during RT.
- •Planned RT course >4 weeks or <3 weeks.
- •Active connective tissue disorders/collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash in the area that will receive RT, systemic lupus erythematosis, or scleroderma.
- •Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
- •Known sensitivity or allergy to silver or nylon.
研究组 & 干预措施
Silver-Plated Technology dressing
SPT dressing (Silverlon) worn for at least for 18 hours a day (removed while showering, bathing, and while having radiation therapy)
干预措施: Silver plated technology (SPT) dressing (Device)
结局指标
主要结局
Grade 2 or greater acute radiation dermatitis (ARD)
时间窗: At 1 month post RT
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.
次要结局
- Use of advanced skin care products(Up to 1 month following completion of RT)
- Patient satisfaction with silver-plated technology (SPT) dressing(At 1 month following completion of RT)
- Radiation Therapy (RT) Completion with use of silver-plated technology (SPT)(At 1 month following completion of RT)
- Silver-plated technology (SPT) Dressing ARD Visual Evaluation(At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month)
- Radiation-Induced Skin Reaction Assessment Scale (RISRAS)(At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month)
研究者
Parul Barry
Clinical Assistant Professor of Radiation Oncology
University of Pittsburgh