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.

主题 447：开发和测试非侵入性冷冻装置，以预防接受紫杉醇治疗乳腺癌的癌症患者化疗引起的手脚周围神经病变。

• 批准号: 10928476
• 负责人: Carole Spangler Vaughn
• 金额: $ 39.98万
• 依托单位: EISANA CORP
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-11 至 2024-09-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10928476
• 关键词: Adverse event; Bladder; Body Temperature; Breast Cancer Patient; Cancer Patient; Chemotherapy-induced peripheral neuropathy; Clinic; Clinical Research; Computer software; Data; Development; Device Safety; Devices; Documentation; Feedback; Hand; Health Personnel; Home; Hour; Human Subject Research; Infusion procedures; Institutional Review Boards; Instruction; Limb structure; Liquid substance; Location; Measurement; Paclitaxel; Pain; Patients; Phase; Prevention; Production; Progress Reports; Pump; Quality of life; Recommendation; Reporting; Risk; Running; Serious Adverse Event; Skin; Specific qualifier value; Statistical Data Interpretation; Surveys; System; Systems Integration; Temperature; Temperature Sense; Testing; Therapeutic; Time; Training; Validation; Variant; Weight; chemotherapy; cohort; cold temperature; design; efficacy study; foot; heat exchanger; human subject; impression; improved; malignant breast neoplasm; next generation; operation; portability; prevent; prototype; recruit; safety study; screening; usability; willingness

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.

这项提议的目的是开发一种原型设备，能够将肢体降温到足以预防化疗引起的周围神经病(CIPN)的水平。这样的产品将使医疗保健提供者能够提供解决方案，以防止CIPN造成的身体疼痛和生活质量下降。将完成以下目标：(1)设计、建造和验证原型，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。项目交付成果是经过验证的Medaco ol™原型设备，其温度在可容忍的治疗范围内可调，并能够冷却到治疗水平8小时以上。通过与Eminence临床研究公司合作获得的用户反馈，该设备将展示在执行所有关键任务时的易用性，而不会出现严重故障。这项研究将进一步提供耐受性的初步迹象，并帮助设计下一代原型，适用于计划在250名患者中进行的第二阶段关键疗效和安全性研究，该原型可在诊所内、在途中和在家中携带。