Phase III Trial to Compare RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Patients using RadiaPlexRx Hydrogel that developed grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation compared to a petroleum-based gel (Aquaphor) commonly used as best supportive care
研究概览
简要总结
Primary Objective:
To determine if RadiaPlexRx Hydrogel can reduce the development of grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation when compared to a petroleum-based gel (Aquaphor) commonly used as best supportive care.
详细描述
The Study Gels:
RadiaPlexRx (requires a prescription) and Aquaphor (over-the-counter) are both gels that are designed to treat irradiated (received radiation) breast skin.
These 2 gels contain different ingredients that may make one gel better than the other to treat irradiated breast skin. RadiaPlexRx contains hyaluronic acid (an ingredient found naturally in skin), aloe vera, and other ingredients that help the skin heal. Aquaphor is made of mostly petroleum that helps protect the skin.
Application of Study Gels:
If you decide to participate in this study, the following steps will be taken:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
- •Patient has breast conserving surgery (lumpectomy) for breast cancer with negative surgical margin
- •Stage Tis,0-3 N0-2 M0
- •Patient will receive irradiation of whole breast. An additional field to treat the supraclavicular / axillary apex lymphatics is allowed, but a separate field to treat the internal mammary chain nodes is not allowed
- •The breast will receive radiation dose greater than or equal to 50 Gy, with or without a boost field to give additional dose to the tumor bed
- •Patient wears bras with cup size larger than A
- •Patient signs informed consent
排除标准
- •Breast cancer treatment with mastectomy
- •Stage T4 breast cancer
- •Patient will require the use of tissue-equivalent bolus during radiation treatment or double treatment of junctions of radiation treatment fields
- •Patient will require treatment to the internal mammary chain lymph node bed using a separate radiation electron field
- •Patient is planned for partial-breast irradiation or Mammo-site treatment.
- •Patient has unhealed wound or rash in the radiation field
- •Patient has allergy to RadiaPlexRx or aloe vera
- •Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development
- •Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Herceptin® [Trastuzumab])
- •Planned accelerated fractionation.
- •Planned radiation therapy to the bilateral breasts
- •Planned breast irradiation in the prone position
结局指标
主要结局
Number of Patients using RadiaPlexRx Hydrogel that developed grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation compared to a petroleum-based gel (Aquaphor) commonly used as best supportive care
时间窗: 6 weeks
次要结局
未报告次要终点