Portable, Patient-Administered Scalp Cooling Cap to Reduce Provider Burden, Improve Patient Access, and Improve Patient Outcomes for Chemotherapy-Induced Alopecia

项目摘要-接受癌症治疗的患者中约有三分之二经历脱发 来自化疗引起的脱发(CIA)。患者说CIA是最令人担忧的副作用之一 化疗，它是导致身体形象不佳、心理健康下降的重要因素，以及 更高的抑郁率。头皮降温，引起血管收缩，保护敏感的毛囊 虽然严酷的化疗药物在血液中的浓度最高，但这是最有效的方法 阻止中情局。最近的一项荟萃分析发现，头皮降温可将明显的CIA风险降低43%，而且灵活 符合头部形状的帽子提供了更好的保护(例如，患者减少了66% 接受紫杉烷)。肿瘤学家和患者对这项技术很热情，但输液中心 由于几个原因：1)中心必须租赁和维护设备；2)工作人员 必须在化疗前、化疗中和化疗后使用该设备；3)一次只有两名患者可以使用该设备 时间；4)使用输液椅可延长3.5小时；5)保险范围不一致 给充电带来了挑战。因此，20%的输液中心提供FDA批准的头皮冷却系统。 患者可以租用凝胶帽系统，但他们必须购买干冰和一个人来实施治疗，这是昂贵的 一个疗程5000美元或更多。为了克服这些挑战，冷静的头脑设计了一款紧凑型， 患者可以在化疗期间以2,000美元的统一费用租用和使用高度便携的设备。这个 该设备包括一个连接到舒适的多叶帽上的电动冷冻机，该帽与患者的头部保持一致。 传感器监测液体温度并调节冷却液流量，无需患者或诊所工作人员干预。 该设备还包括一个车载电池和汽车充电器，使患者可以继续输液后的冷却 离开输液中心后，腾出椅子给其他患者。该设备完全由患者管理， 输液中心只需要提供一个电源插座和冰块(化疗的标准)。在一个 第一阶段SBIR(1R43CA254560-01A1)，Cooler Heads开发了培训材料并进行了可用性 测试表明，患者可以在没有医疗保健提供者支持的情况下按预期使用该设备。在……里面 这是第二阶段的后续研究，Cooler Heads建议进行一项前瞻性的临床研究，以确定疗效 用于降低严重CIA风险的患者管理的设备。瞄准。确立头皮的功效 使用患者自己管理的设备进行冷却。里程碑：证明患者使用的设备有效 与文献中报道的提供者管理的头皮降温相当或更好。成功标准：≥ 50%的患者在最后一次治疗后3周≤脱发50%。影响-如果显示为提供好处 与提供者管理的头皮冷却设备相比，这种患者管理的设备具有以下潜力 改变头皮降温的提供方式，满足NCI癌症登月计划的优先事项，减少主要副作用 通过减少阻碍大多数患者获得这一有效技术的障碍，癌症治疗的最新进展。

PROJECT SUMMARY—Approximately two-thirds of patients undergoing cancer treatment experience hair loss from chemotherapy-induced alopecia (CIA). Patients say CIA is one of the most concerning side effects of chemotherapy, and it is a significant contributor to poor body image, decreased psychological well-being, and higher rates of depression. Scalp cooling, which causes vasoconstriction that protects sensitive hair follicles while harsh chemotherapeutic agents are at the highest concentrations in the blood, is the most effective way to prevent CIA. A recent meta-analysis found scalp cooling reduced the risk of significant CIA by 43%, and flexible caps that conform to the shape of the head provide even better protection (e.g., 66% reduction in patients receiving taxanes). Oncologists and patients are enthusiastic about this technology, but infusion centers have been slow to make it available for several reasons: 1) the center must lease and maintain the device; 2) staff must administer the device before, during, and after chemotherapy; 3) only two patients can use the device at a time; 4) use extends occupation of the infusion chair by up to 3.5 hours; and 5) inconsistent insurance coverage presents challenges for charging. As a result, < 20% of infusion centers offer FDA-cleared scalp cooling systems. Patients can rent gel cap systems, but they must source dry ice and a person to administer the treatment, costing $5,000 or more over a course of therapy. To overcome these challenges, Cooler Heads designed a compact, highly-portable device patients can rent and use for a flat fee of $2,000 for the duration of chemotherapy. The device includes an electric chiller connected to a comfortable multi-leaf cap that conforms to the patient’s head. Sensors monitor fluid temperature and modulate coolant flow without intervention by the patient or clinic staff. The device also includes an onboard battery and car charger that allow patients to continue post-infusion cooling after leaving the infusion center, freeing up the chair for other patients. The device is fully patient administered, and the infusion center would only need to provide an electrical outlet and ice (standard for chemotherapy). In a Phase I SBIR (1R43CA254560-01A1), Cooler Heads developed training materials and conducted usability testing to demonstrate patients could use the device as intended without support from healthcare providers. In this follow-on Phase II, Cooler Heads proposes to conduct a prospective clinical study to establish the efficacy of the patient-administered device for reducing the risk of significant CIA. Aim. Establish the efficacy of scalp cooling with a patient-administered device. Milestone: Demonstrate patient-administered device has efficacy comparable to or better than provider-administered scalp cooling as reported in literature. Success Criterion: ≥ 50% of patients have hair loss of ≤ 50% at 3 weeks after final treatment. Impact—If shown to provide benefit comparable to provider-administered scalp cooling devices, this patient-administered device has the potential to transform how scalp cooling is delivered, meeting NCI’s Cancer Moonshot priority for reducing major side effects of cancer therapy by reducing the barriers that prevent most patients from accessing this effective technology.