PREventing CHemotherapy Induced Neuropathy (PreChIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 主要终点
- Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
研究概览
简要总结
The project is designed to study the use of localized hypothermia alone, or with compression to the limbs during chemotherapy infusion for the prevention of chemotherapy induced peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical activity will be studied. The study will be conducted on healthy volunteers and cancer patients receiving taxane chemotherapy.
详细描述
Localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect of chemotherapy: chemotherapy-induced peripheral neuropathy (CIPN). There are no reliable methods for the prevention or the treatment of CIPN. On the basis of the dose-related pathophysiology of CIPN, the investigators hypothesize that reducing the delivery of the toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through hypothermia may reduce the occurrence of CIPN. The proposed potential treatment method would aim to reduce the development of CIPN. This project comprises of a healthy subject trial to investigate the best tolerated temperature which will be used in cancer subject trial to investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with pressure) in the prevention of CIPN in cancer subjects undergoing taxane-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Healthy subjects (Hypothermia)
To investigate the safety and tolerability of limb hypothermia in subjects without cancer
干预措施: Hypothermia (Device)
Healthy subjects (Cryocompresion)
To investigate the safety and tolerability of cryocompression in subjects without cancer
干预措施: Cryocompression (Device)
Cancer subjects (Hypothermia)
To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy.
干预措施: Hypothermia (Device)
Cancer subjects (Cryocompresion)
To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy.
干预措施: Cryocompression (Device)
结局指标
主要结局
Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
时间窗: From the start of assessment until study completion, an average of 3 years
Number of cancer patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
时间窗: From the start of assessment until study completion, an average of 3 years
次要结局
未报告次要终点