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临床试验/jRCTs021200031
jRCTs021200031已完成不适用

Study of the preventive effect of laftidine for chemotherapy-induced peripheral neuropathy in patients receiving paclitaxel

未提供0 个研究点目标入组 40 人开始时间: 2021年1月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Grade 2 or higher peripheral neuropathy

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 Trial
干预模型
Single Assignment
主要目的
Prevention Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age 0month 0week old over 至 No limit(—)
性别
All

入选标准

  • 1.The age at the time of obtaining consent is 18 years or older
  • 2.Patients with cytopathological or clinical diagnosis of non-small cell lung cancer
  • 3.Cases where surgical treatment, definitive radiation therapy, and chemoradiation therapy are not indicated (excluding palliative irradiation)
  • 4.Patients scheduled to be treated by the treatment including paclitaxel
  • 5.Patients scheduled to treated by carboplatin+paclitaxel therapy (batch) or carboplatin+paclitaxel (batch) +pembrolizumab therapy
  • (or patients with Grade 2 or higher (CTCAE ver5.0.) CIPN by split paclitaxel)
  • 6.Patients who are not recieving anti-ulcer drugs or are receiving anti-ulcer drugs but are considered to be able to change to lafutidine
  • 7.Patients who can ingest orally
  • 8.Patients who can recieve informed consent

排除标准

  • 1.Patients who receive paclitaxel as chemoradiotherapy
  • 2.Patients who are pregnant or breastfeeding
  • 3.Patients with a history of drug hypersensitivity or allergy to lafutidine
  • 4.Patients with a history of drug hypersensitivity or allergy to paclitaxel
  • 5.Patients with contraindications reg arding paclitaxel administration, such as those with a history of hypersensitivity to polyoxyethylene castor oil-containing preparations (eg, cyclosporine injection) or severe myelosuppression
  • 6.Patients with a history of severe drug hypersensitivity to other drug s
  • 7.Patients who have already taken anti-ulcer drugs and cannot chang e to lafutidine
  • 8.Patients who cannot judg e subjective symptoms related to peripheral neuropathy due to sympto
  • ms by brain metastasis or neuropathy
  • 9.Patients originaly had Grade2(CTCAE ver5.0.) or higher peripheral neuropathy
  • 10.Patients judg ed to be inappropriate by doctor to safely carry out this reserch

结局指标

主要结局

Grade 2 or higher peripheral neuropathy

Common Terminology Criteria for Adverse Events(CTCAE) version 5.0.

次要结局

  • Grade 3 or higher peripheral neuropathy

研究者

发起方
未提供

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