The Efficacy of Compression/Ice Gloves/Socks in Patients With UTD1-induced Neuropathy.
Reducing Peripheral Sensory and Motor Neuropathy Induced by UTD1 With Compression/Ice Gloves/Socks, a Multi-center Prospective Phase III Trial (YBCSG-20-02).
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Xichun Hu, MD,Phd
- 电话号码:13816110335
- 邮箱:xchu2009@hotmail.com
研究联系人备份
- 姓名:Jian Zhang, MD,Phd
- 电话号码:18017312991
- 邮箱:zhangjian1001@csco.ac.cn
学习地点
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Shanghai、中国
- 招聘中
- Fudan University Shanghai Cancer Center
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接触:
- Jian Zhang, PHD
- 电话号码:021-64175590
- 邮箱:syner2000@163.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Female ,18-75 years;
- Documentation of histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer;
- The participants is going to receive UTD1 based regimen at least 2 cycles;
- The baseline peripheral sensory neuropathy and peripheral motor neuropathy (CTCAE 5.0) is less than 1 grade;
- ECOG score ≤1;
Adequate organ and bone marrow function defined as follows within 7 days before enrollment:
Absolute Neutrophil Count (ANC) ≥1,500/mm 3 (1.5 ×10 9/L), white blood cell count (WBC) ≥3.5×10 9/L, platelets ≥75,000/mm 3 (75×10 9/L), hemoglobin ≥9 g/dL (90 g/L), no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulation factor within 7 days.
Serum creatinine ≤1.5 × Upper Limit of Normal (ULN); AST, ALT, ALP exceeding the upper limit of normal but ≤ 2.5 × ULN when no liver metastasis; AST, ALT, ALP exceeding the upper limit of normal but ≤ 5 × ULN when liver metastasis.
- Expected survival time ≥12 weeks;
- No history of serious heart, lung, liver, kidney and other important organ diseases;
- Signed informed consent;
- Good compliance to the protocol;
- Women of childbearing age must already be using reliable contraception, a pregnancy test (blood or urine) is performed within 14 days before enrollment and the result was negative (if positive, pregnancy must be ruled out by ultrasound), and willing to use an appropriate methods of contraception during the trial and for 8 weeks after completion of the trial.
Exclusion Criteria:
- Previous treatment of UTD1;
- Severe uncontrolled infection.
- Patients with leptomeningeal metastases, symptomatic brain metastases, spinal cord compression, or brain or leptomeningeal disease detected on imaging at screening (patients who had completed local brain therapy 21 days before treatment and had stable symptoms and no cerebral hemorrhage confirmed by imaging were eligible).
- Patients whose hands/feet are not suitable for wearing the compression/ice gloves/socks;
- Other conditions unsuitable for the enrollment, including but not limited to illiteracy, inability to complete the peripheral neurotoxicity scale, and other neurological abnormalities affecting the accurate assessment of neurotoxicity, etc.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:blank control group
No intervention.
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实验性的:compression glove/sock group
Patients in group B wear pressure gloves/socks of a smaller size for both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
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Patients in group B wear pressure gloves/socks of a smaller size for both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
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实验性的:ice glove/sock group
Patients in group C wear ice gloves/socks on both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
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Patients in group C wear ice gloves/socks on both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Difference in the incidence of ≥ grade 2 peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment
大体时间:6 weeks
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6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in incidence of total peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
大体时间:6 weeks
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6 weeks
|
|
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Difference in the incidence of ≥grade 2 peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
大体时间:6 weeks
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6 weeks
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Difference in incidence of total peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.
大体时间:6 weeks
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6 weeks
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Differences in peripheral neurotoxicity scale scores assessed by Functional Assessment of Cancer Therapy-breast after 2 cycles of UTD1 treatment.treatment.
大体时间:6 weeks
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6 weeks
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Number of participants with device-related adverse events
大体时间:6 weeks
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Number of participants experiencing adverse events related to the use of cryotherapy gloves/socks or compression gloves/socks, including skin injury, pain, discomfort, cold intolerance, numbness, and other device-related adverse events, assessed according to CTCAE v5.0.
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6 weeks
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合作者和调查者
调查人员
- 首席研究员:Ting Li、fudan university shanghai cancer center shanghai, China
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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