NCT07638774招募中不适用
Reducing Peripheral Sensory and Motor Neuropathy Induced by UTD1 With Compression/Ice Gloves/Socks, a Multi-center Prospective Phase III Trial (YBCSG-20-02).
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Difference in the incidence of ≥ grade 2 peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment
研究概览
简要总结
This study is a prospective, multicenter, phase Ⅲ trial to evaluate of the compression/ice gloves/socks efficacy in UTD1-induced peripheral sensory and motor neuropathy. 324 patients will be included. All patients will be randomly divided into three groups at a ratio of 1:1:1. Group A is the blank control group, group B is the compression glove/sock group, and group C is the ice glove/sock group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
blank control group
No Intervention
No intervention.
compression glove/sock group
Experimental
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.
干预措施: compression glove/sock (Device)
ice glove/sock group
Experimental
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.
干预措施: ice glove/sock (Device)
结局指标
主要结局
Difference in the incidence of ≥ grade 2 peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment
时间窗: 6 weeks
次要结局
- Differences in peripheral neurotoxicity scale scores assessed by Functional Assessment of Cancer Therapy-breast after 2 cycles of UTD1 treatment.treatment.(6 weeks)
- Difference in incidence of total peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.(6 weeks)
- Difference in the incidence of ≥grade 2 peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.(6 weeks)
- Difference in incidence of total peripheral motor neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment.(6 weeks)
- Number of participants with device-related adverse events(6 weeks)
研究者
Jian Zhang,MD
Director of the phase I clinical trial department
Fudan University
研究点 (1)
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