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临床试验/NL-OMON42804
NL-OMON42804已完成不适用

Assessment of the responsiveness of the Rasch-built, CIPN-specific questionnaire (CIPN-RODS) to clinical changes in patients undergoing neurotoxic chemotherapy. - Assessment of the CIPN-RODS in patients undergoing neurotoxic chemotherapy.

niversitair Medisch Centrum0 个研究点目标入组 5 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
已完成
发起方
入组人数
5

研究概览

简要总结

Trial is onging in other countries

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Subjects must be candidates for chemotherapy including in the treatment plan platinum-based drugs or taxanes at doses expected to be potentially neurotoxic
  • 2. Male and female subjects who are 18 years of age or older.
  • 3. Subjects must give informed consent by signing and dating an informed consent form prior to study entry.
  • 4. Subjects must have a Karnofsky performance score greater than or equal to 70.

排除标准

  • 1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
  • 2. Concomitant neurologic conditions, e.g., brain tumor, spinal or brain metastases.
  • 3. Severe depression that in the opinion of the Investigator would complicate the assessments.
  • 4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
  • 5. Subjects with a known presence of peripheral nerve damage due to another illness or medication.
  • 6. Subjects who are currently receiving another medication that has known potential to produce neurologic peripheral nerve toxicity (e.g. metrodiazole or isoniazid).

研究者

发起方
niversitair Medisch Centrum

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