跳至主要内容
临床试验/KCT0008371
KCT0008371尚未招募Unknown

A randomized controlled trial using surgical gloves to prevent chemotherapy-induced peripheral neuropathy by paclitaxel in breast cancer patients (AIUR trial)

The Catholic University of Korea, Incheon St. Mary's Hospital0 个研究点目标入组 104 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
104

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
19(Year) 至 69(Year)(—)
性别
Female

入选标准

  • Age greater or equal to 19 years, under 70 years old
  • -Stage II-III breast cancer
  • -No distant metastasis
  • -Patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel for at least 12 weeks
  • -Signed informed consent
  • -Eastern Cooperative Oncology Group (ECOG) performance status = 2 (Karnofsky =60%)

排除标准

  • -Recurred breast cancer
  • -Patients who have previously received treatment that could cause neuropathy; taxane or platinum-based chemotherapy, antitubulins, proteasome inhibitors
  • -Known history of neuropathy
  • -Chronic kidney disease
  • -Raynaud’s phenomenon
  • -Peripheral vascular disease; peripheral arterial ischemia
  • -Cold intolerance
  • -Allergy in natural rubber latex or surgical gloves
  • -Patients who have dermatitis, wound, or musculoskeletal problems in hand at enrollment
  • -Current use medications which may mitigate chemotherapy-induced peripheral neuropathy; duloxetine, gabapentin/pregabalin, BAK (topical amitriptyline, ketamine, ±baclofen), oral cannabinoids, tricyclic antidepressants, ganglioside-monosialic acid
  • -Patients' condition that interferes with understanding and submitting the consent form

研究者

发起方
The Catholic University of Korea, Incheon St. Mary's Hospital

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