跳至主要内容
临床试验/DRKS00032560
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

发起方
Klinik für Strahlentherapie und Radioonkologie

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