Effect of Real-time Pressure Controllers on Objective and Subjective Symptoms of Albumin Paclitaxel-induced Peripheral Neuropathy: a Prospective Controlled Research Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- CIPN-related symptoms, as assessed by changes in tactile sensitivity at pretreatment baseline CIPN incidence.The Patient Neurotoxicity Questionnaire (PNQ) was used to assess and grade the incidence and severity of CIPN.
研究概览
简要总结
The purpose of the real-time pressure controller proposed in this experiment is to overcome the deficiencies of the existing technology and provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, with the pressure decreasing in a sequential manner from the distal end (toes/fingers) to the proximal end (wrists, limbs). The application of this device is of great clinical significance to reduce the peripheral neurotoxicity of paclitaxel and to improve patients' drug compliance. The application of cold compresses or gloves or socks with certain wrapping force is not suitable for the Chinese population, and the acceptance degree of Chinese patients is poor, and the pressure gloves lack individual specificity, and the precise control of pressure for real-time regulation cannot be realized, and the clinical effect is relatively poor. The purpose of this utility model device is to overcome the deficiencies of the existing technology, to provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, and the pressure decreases in a sequential manner from the distal end (toes/fingers) to the proximal end (wrist, limb). After applying for the patent, it will be transformed into the market, which has a vast space of medical benefits and market benefits. Paclitaxel is the cornerstone drug in breast cancer chemotherapy, and the neuropathy it causes is often a key factor leading to drug reduction or discontinuation, so opening up the prevention of peripheral neuropathy caused by paclitaxel is of great clinical use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed written informed consent;
- •Age ≥18 years and ≤75 years at enrollment, male or female patients;
- •Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
- •Suitable for albumin-paclitaxel antitumor therapy;
- •Cardiopulmonary, hepatic, renal, and coagulation functions are basically normal.
排除标准
- •Patients with prior chemotherapy;
- •Patients with a prior diagnosis of peripheral neuropathy;
- •Patients with a prior diagnosis of associated comorbidities (e.g., diabetes mellitus).
研究组 & 干预措施
No intervention
two-handed intervention
干预措施: Real Time Pressure Controller (Device)
结局指标
主要结局
CIPN-related symptoms, as assessed by changes in tactile sensitivity at pretreatment baseline CIPN incidence.The Patient Neurotoxicity Questionnaire (PNQ) was used to assess and grade the incidence and severity of CIPN.
时间窗: through study completion, an average of 1 year
From the time a patient begins albumin paclitaxel therapy until the patient's treatment on this regimen is completed, or during albumin paclitaxel therapy, adverse reactions due to pressure gloves that result in patient patient disenrollment or voluntary.
次要结局
未报告次要终点