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

项目总结-大约三分之二的癌症治疗患者经历脱发 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，它是一个显着的贡献者身体形象差，心理健康下降， 更高的抑郁率。头皮冷却，导致血管收缩，保护敏感的毛囊 虽然苛刻的化学治疗剂在血液中处于最高浓度，但是 阻止中情局最近的一项荟萃分析发现，头皮冷却可将CIA的风险降低43%， 与头部形状一致的帽提供了更好的保护（例如，患者减少66% 接受紫杉烷）。肿瘤学家和患者对这项技术充满热情，但输液中心 由于以下几个原因，该中心迟迟未能提供该设备：1）该中心必须租用和维护该设备; 2）工作人员 必须在化疗前、化疗期间和化疗后使用该装置; 3）只有两名患者可以同时使用该装置。 时间; 4）使用延长了输液椅的占用时间长达3.5小时;以及5）保险范围不一致 对充电提出了挑战。因此，< 20%的输液中心提供FDA批准的头皮冷却系统。 病人可以租用凝胶帽系统，但他们必须购买干冰和一个人来进行治疗， 一个疗程的治疗费用在5,000美元或以上。为了克服这些挑战，Cooler Heads设计了一款紧凑， 在化疗期间，高度便携的设备患者可以以2,000美元的固定费用租用和使用。的 该设备包括一个电冷却器，连接到一个舒适的多叶帽，符合病人的头部。 传感器监测流体温度并调节冷却剂流量，而无需患者或诊所工作人员的干预。 该设备还包括一个板载电池和车载充电器，允许患者继续输液后冷却 离开输液中心后，腾出椅子给其他病人。该装置完全由患者管理， 输液中心只需要提供电源插座和冰块（化疗的标准）。中 第I阶段SBIR（1 R43 CA 254560 - 01 A1），冷却器头开发培训材料并进行可用性测试 测试以证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器械。在 在第二阶段的后续研究中，Cooler Heads建议进行一项前瞻性临床研究，以确定其疗效。 降低重大CIA风险的患者给药器械。瞄准建立头皮的功效 用患者给药装置冷却。里程碑：证明患者给药器械有效 与文献中报道的提供者施用的头皮冷却相当或更好。成功标准：≥ 50%的患者在最终治疗后3周脱发≤ 50%。影响-如果显示可提供获益 与提供者施用的头皮冷却装置相比，这种患者施用的装置具有潜力， 改变头皮冷却的方式，满足NCI的癌症登月计划优先级，以减少主要副作用 通过减少阻止大多数患者获得这种有效技术的障碍，

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.