Topic 447: Development and testing of a non-invasive cryo-device to prevent chemotherapy-induced peripheral neuropathy in hands and feet of cancer patients receiving Taxol for breast cancer.

本提案的目的是开发一种原型装置，能够将四肢冷却到足以预防化疗诱导的周围神经病变（CIPN）的水平。这种产品将使医疗保健提供者能够提供一种解决方案，以防止由CIPN引起的身体疼痛和生活质量下降。将完成以下目标：(1)设计、构建和验证原型，以及(2)在接受化疗的小患者队列中进行可用性和耐受性研究。项目最终交付的产品是一个经过验证的Medacool™原型设备，该设备具有可调节的温度，在可容忍的治疗范围内，能够冷却到治疗水平8小时以上。通过与卓越临床研究公司合作获得的用户反馈，该设备将证明在执行所有关键任务时易于使用，没有严重故障。该研究将进一步提供耐受性的初步指标，并帮助设计适用于临床、运输和家庭携带的下一代原型，用于计划在250名患者中进行的II期关键疗效和安全性研究。

The objective of this proposal is to develop a prototype device capable of cooling extremities to a level sufficient for prevention of chemotherapy-induced peripheral neuropathy (CIPN). Such a product will enable healthcare providers to make available a solution to prevent the physical pain and reduction in quality of life resulting from CIPN. The following Aims will be completed: (1) design, build, and validate prototypes, and (2) conduct usability and tolerability studies in a small patient cohort undergoing chemotherapy. The end of project deliverable is a validated Medacool™ prototype device with adjustable temperature within a tolerable therapeutic range with the ability to cool to therapeutic levels for 8+ hours. Through user feedback acquired in partnership with Eminence Clinical Research, Inc., the device will demonstrate ease of use in performing all critical tasks with no critical faults. The study will further provide initial indications of tolerability as well as aid in the design of a next generation prototype amenable to in-clinic, in-transit, and in-home portability for a planned Phase II pivotal efficacy and safety study in 250 patients.