Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
研究概览
简要总结
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.
详细描述
The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years and older
- •Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast
- •Able to apply lotion to treatment area at least twice daily during radiation course
- •All surgical sites healed
- •No evidence of infection
- •No history of sensitivity to any component in Aquaphor or Difensa53
排除标准
- •Prior history of radiation therapy (RT) to that site
- •Known dermatologic conditions affecting skin in radiation port
- •Concurrent chemotherapy
- •Skin infection in radiation port
- •History of sensitivity to Aquaphor or Difensa53 component
研究组 & 干预措施
Single Arm
Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor
干预措施: Difinsa53 (Drug)
Single Arm
Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor
干预措施: Aquaphor (Drug)
结局指标
主要结局
Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
时间窗: 8 weeks
A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.
次要结局
未报告次要终点