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临床试验/NL-OMON44353
NL-OMON44353招募中不适用

Prospective, multi-centre trial to evaluate effectiveness of 45-min and 20-min post-infusion cooling time for patients treated with scalp cooling to prevent paclitaxel-induced alopecia - COP

eids Universitair Medisch Centrum0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)

入选标准

  • * Patients receiving weekly-administered paclitaxel-containing chemotherapy (minimal of 3 planned administrations) in a dose of 80-90 mg/m2
  • o Paclitaxel monotherapy
  • o Paclitaxel in combination with carboplatin
  • o Paclitaxel in combination with monoclonal antibodies:
  • * Bevacizumab
  • * Trastuzumab
  • * Age * 18 years
  • * WHO performance status 0-2
  • * Survival expectation must be > 3 months
  • * Written informed consent according to the local Ethics Committee requirements

排除标准

  • * Treatment with paclitaxel in sequential schemes with other alopecia inducing agents such as (paclitaxel monotherapy after adriamycin, cyclophosphamide (AC) or paclitaxel monotherapy after 5-fluouracil, epirubicin, cyclophosphamide (FEC) treatment)
  • * Alopecia before the start of the study
  • * Rare cold-related disorders, like:
  • o Cold sensitivity
  • o Cold agglutinin disease
  • o Cryoglobulinaemia
  • o Cryofibrinogenaemia
  • o Cold posttraumatic dystrophy

研究者

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