高压氧疗法改善白蛋白结合型紫杉醇诱发周围神经病变的有效性和安全性
高压氧疗法改善白蛋白结合型紫杉醇诱导的周围神经病变的疗效与安全性:一项随机临床试验
The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Kun Wang, PhD
- 电话号码:+8615989223200
- 邮箱:gzwangkun@126.com
研究联系人备份
- 姓名:Yingcong Lin, Master of Medicine
- 电话号码:+8618666885689
- 邮箱:18666885689@163.com
学习地点
-
-
Guangdong
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Guangzhou、Guangdong、中国、510080
- 招聘中
- Guangdong Provincial People's Hospital
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接触:
- Kun Wang
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接触:
- Wang Kun PhD, Doctor
- 电话号码:15989223200
- 邮箱:gzwangkun@126.com
-
Guangzhou、Guangdong、中国
- 招聘中
- Guangdong Provincial People's Hospital
-
接触:
- Yingcong Lin, master of medicine
- 电话号码:+86 18666885689
- 邮箱:18666885689@163.com
-
接触:
- Kun Wang, PhD
- 电话号码:+8613922118086
- 邮箱:gzwangkun@126.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- aged ≥ 18 years and ≤ 75 years, female
- early-stage breast cancer or locally advanced breast cancer
- Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel
- The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4/10.
- The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.
Exclusion Criteria:
- Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.
- Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.
- Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).
- Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.
- Karnofsky Performance Status score < 80
- Patients with any other conditions that the investigator deems unsuitable for participation in the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:HBOT group
hyperbaric oxygen intervention:Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA) |
Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA) |
|
其他:Control group
Standard care |
Standard care |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
EORTC QLQ-CIPN20 subscales
大体时间:baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
|
Self-reported neuropathy was assessed with the European Organisation for the Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20, which contains 20 items divided into three subscales assessing sensory, motor and autonomic symptoms. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much'. Scores were transformed to a 0-100 scale, with higher scores representing more complaints |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
NCI-CTCAE 5.0
大体时间:baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
Patients will be assessed by professional physicians in accordance with the CTCAE Version 5.0 grading criteria. The evaluated items include peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia, myalgia, arthralgia, and neuralgia, each of which will be graded on a scale from Grade 0 to Grade 4 |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
|
EORTC QLQ-C30
大体时间:baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
QoL was assessed with the EORTC QLQ-C30, which contains five functional scales, a global health status/QoL scale, three symptoms scales and six single items. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much', except for the global QoL scale that ranges from 1 'very poor' to 7 'excellent'. Scores were transformed to a 0-100 scale, where higher scores indicate better functional status and quality of life (QoL), whereas higher scores reflect more severe symptoms. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
|
BPI-SF
大体时间:baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
Patient-reported pain severity and functional interference was assessed using the well-validated Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory-Short Form (BPI-SF) includes four items that assess average, worst, least, and current pain severity over the past 24 hours. Each pain severity item is rated on an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Moreover, seven BPI items-assessing interference with daily activities/functions-are scored using the same 11-point scale (0 = does not interfere; 10 = completely interferes), consistent with established methodology. The seven items were summed to obtain a total interference score. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
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Nerve Conduction Velocity
大体时间:baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
Sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (SNCV) will be measured. The nerves measured included the tibial nerve, sural nerve, median nerve, and ulnar nerve. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
合作者和调查者
调查人员
- 首席研究员:Kun Wang、Guangdong Provincial People's Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
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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