EUCTR2018-001705-91-DK进行中（未招募）1 期
MELADERM-trial: Melatonin cream against acute radiation dermatitis in patients with early breast cancer: a pivotal phase 2, double-blind, randomized, placebo-controlled trial
Center for Perioperative Optimization, Department of Surgery, Herlev Hospital0 个研究点目标入组 80 人开始时间: 2018年7月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Diagnosed with early breast cancer
- •Over 49 years old
- •Have had radical tumor resection surgery
- •Follows treatment regimens and follow-up at Rigshospitalet
- •Written informed consent after written and verbal information
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Inability to understand Danish, written or spoken
- •Mental illness*
- •Previous therapy with ionizing radiation in the thoracic or neck area
- •Use of bolus for radiation therapy**
- •* Defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance. ** A bolus is a material which has dose absorption properties equivalent to tissue. It is placed on the irradiated area to alter dosing or target of the radiation therapy
研究者
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