ACTRN12612000662864已完成2 期
Randomised, controlled phase II trial of simvastatin as prophylaxis against radiation–induced skin toxicity in breast cancer patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Patients with resected invasive cancer or carcinoma in-situ of the breast treated with either breast-conserving surgery or mastectomy who are planned to receive adjuvant radiation therapy.
- •Radiation fields may include the breast, chest wall, supraclavicular and/or axillary regions. Acceptable dose fractionation schedules include 50Gy in 25 fractions, 45Gy in 20 fractions, 42.5Gy in 16 fractions or 40Gy in 15 fractions, with or without a boost.
- •Patients may be taking adjuvant hormonal therapy and/or trastuzumab for breast cancer
- •Patients may have received prior adjuvant chemotherapy
- •Patients have given written informed consent
排除标准
- •Patients receiving other hypofractionated radiation schedules
- •Patients requiring the use of skin bolus with their radiotherapy
- •Patients with pre-existing ulceration, infection or skin rashes within the radiation treatment field
- •Known contra-indication to statins including hypersensitivity, active liver disease or unexplained persistent elevation of transaminases, concomitant administration of potent CYP3A4 inhibitors
- •Concurrent chemotherapy
- •Patients currently on statins or taken within the last 6 weeks
- •Current pregnancy or breast-feeding
研究者
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