DRKS00032560招募中3 期
on-Invasive Physical Plasma for Preventing Radiation Dermatitis in Breast Cancer: A Randomised Double-Blind Placebo-Controlled Trial - NIPP-RD III
Klinik für Strahlentherapie und Radioonkologie0 个研究点目标入组 140 人开始时间: 2024年1月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •subjects will only be included in the study if they meet all of the following criteria:
- •- age = 18 years (no upper limit)
- •- breast-conserving surgery for breast cancer or carcinoma in situ (C50.9)
- •- whole-breast irradiation
- •- moderately hypofractionated radiation regimen, with or without a boost to the tumour bed (simultaneous-integrated or sequential)
- •- oral and written informed consent
排除标准
- •subjects will not be included in the study if any of the following criteria apply:
- •- synchronous metastatic disease
- •- mastectomy
- •- reconstruction with breast implant
- •- impaired surgical wound healing at the time of radiation treatment initiation
- •- alternative fractionation regimens
- •- history of ipsilateral breast irradiation
- •- any pre-existing dermatological disorder
- •- active dermatitis
- •- current treatment with topical or oral corticosteroids
- •- patient refusal to participate
- •- subjects without legal capacity to understand the nature, scope, significance, or consequences of a clinical trial
研究者
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