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
