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临床试验/NCT04237194
NCT04237194Unknown不适用

A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy

Carsten Dahl Mørch1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Change of Nerve fiber excitability

研究概览

简要总结

To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers

详细描述

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of many chemotherapeutic agents, especially antineoplastic agents. To limit the nerve damages, early detection and management of CIPN is crucial and leaves an urgent demand for new diagnostic tools. Perception threshold tracking has enabled assessments of nerve excitability tests of both small and large sensory nerves and may be used to assess CIPN at early stages. The purpose of this study is to examine whether a new nerve excitability test can detect changes in the membrane properties of the small and large nerve fibers during chemotherapy treatment.

In this study nerve excitability tests will be performed with 2 different electrodes using a novel perception threshold tracking technique to assess the Nerve excitability of small and large fibers. Further quantitative sensory tests (QST) will be performed to estimate the vibration threshold, warm and cool perception thresholds, heat and cold pain thresholds, and perceived intensity to static mechanic stimulations will be assessed. Symptoms of CIPN will be assessed using the Common Terminology Criteria for Adverse events scale and a Quality of Life Questionnaire CIPN twenty-item scale.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • > 18 years
  • Histopathologically verified breast cancer
  • Performance Status according to WHO/ECOG (PS) 0-2
  • Candidate for adjuvant standard treatment with EC and Paclitaxel
  • Not previously treated with chemotherapeutic agents
  • Neurological examination without pathological findings
  • Willingness to voluntarily sign an informed consent

排除标准

  • Previously neoadjuvant treatment with chemotherapy
  • Receives prophylactic bone marrow stimulants
  • Diabetes mellitus
  • Opioid requirement
  • Symptomatic neurosensory disorders
  • Neurological diseases, such as sclerosis and epilepsy
  • Alcohol abuse
  • "Palmar-plantar erythrodysesthesia syndrome" / ulceration of hands or feet
  • Cannot understand written or oral information in Danish
  • Inability to cooperate

结局指标

主要结局

Change of Nerve fiber excitability

时间窗: The difference between baseline and the 6 months follow-up

The chronaxie and the rheobase to rectangular stimuli, the accommodation to triangular stimuli, and the electrotonus to subthreshold hyperpolarizing pre-pulses for large and small sensory nerves from the excitability measure.

次要结局

  • Change of Quantitative sensory test(The difference between baseline and the 6 months follow-up)
  • Changed of CTCAE(The difference between baseline and the 6 months follow-up)
  • Change of CIPN20.(The difference between baseline and the 6 months follow-up)

研究者

发起方
Carsten Dahl Mørch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carsten Dahl Mørch

Associate Professor

Aalborg University

研究点 (1)

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