NCT04238728已完成1 期
An Unblinded, Open-label Study Evaluating the Safety of Silverlon to Manage Radiation Dermatitis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number of Participants With an Adverse Skin Event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Number of Participants With an Adverse Skin Event
时间窗: 12 weeks
次要结局
- Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score(2 weeks)
- Mean Radiation Induced Skin Reaction Assessment Scale(2 weeks post radiation therapy, approximately 6.5 weeks)
研究者
Julie Ryan Wolf
Associate Professor
University of Rochester
研究点 (2)
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