?Drawing on the experiences of patients and healthcare providers, Cooler Heads Care has engineered a low-cost, portable, sensor-enhanced scalp cooling device and smartphone app patients can use to prevent the disfiguring effects of chemotherapy-induced alopecia (CIA). Despite the efficacy of scalp cooling, most infusion centers do not offer scalp cooling because the devices are bulky, expensive, and burdensome. Commercialization of a portable, patient-administered device has the potential to eliminate provider burden; reduce costs; and improve patient access, well-being, and quality of life. Each year, > 650,000 Americans undergo chemotherapy, and > 65% experience CIA. Patients rank CIA as 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?all of which contribute to higher costs and poorer outcomes. Multiple trials have shown that cooling the scalp to 3o to 5o C during and after chemotherapy is the most effective means for preventing CIA. Unfortunately, only about 20% of infusion centers offer scalp cooling because 1) the center must lease / maintain the device; 2) staff must administer it; 3) only two patients can use it at a time; 4) it extends use of the infusion chair by up to 3.5 hours; and 5) inconsistent insurance coverage presents challenges for charging. Patients can rent gel cap systems, but dry ice and a person to administer the treatment can cost > $5,000. To overcome these challenges, Cooler Heads designed a patient-administered portable device the size of a carry-on suitcase that patients can rent for $800 for the duration of chemotherapy. The device includes an electric chiller connected to a comfortable multi-leaf cap that expands to fit the patient?s head, and sensors in the cap monitor scalp temperature and modulate coolant flow. An onboard battery and car charger allow mobile use after infusions, freeing up chairs for other patients. A smartphone app provides patient reminders and instructional videos, tracks infusion times, and provides tips on hair care. The FDA has determined Cooler Heads needs to 1) develop training materials and conduct usability testing to demonstrate patients can use the device as intended (Phase I SBIR) and 2) conduct a trial to demonstrate the patient-administered device is efficacious (future Phase II). Thus, Cooler Heads proposes the following:
Aim. Demonstrate the feasibility of delivering scalp cooling with a patient-administered device. Sub-Aim 1. Develop and refine training materials to demonstrate the use of the device. Sub-Aim 2. In a study with 20 healthy adults from diverse backgrounds, assess the usability of the device and feasibility of self-administration in a simulated chemotherapy infusion scenario. Milestones: 1) ? 80% of participants can complete critical tasks without outside assistance, 2) ? 90% can complete them with phone support, 3) avg. setup time ? 10 min. Impact: This device has the potential to transform the delivery of scalp cooling, meeting NCI?s Cancer Moonshot priority for reducing major side effects of cancer therapy by reducing barriers that prevent most patients from accessing this effective technology.
Patients facing the prospect of chemotherapy consistently report that hair loss is one of their biggest concerns, and patients who experience hair loss due to chemotherapy suffer from poor body image, decreased psychological well-being, and higher rates of depression. Cooling the scalp before, during, and after chemotherapy greatly reduces the risk of hair loss from chemotherapy, but the available devices have several limitations that prevent about 80% of chemotherapy infusion centers from offering them to patients. This study is designed to test the feasibility of using a portable, patient-administered scalp cooling device, which is expected to eliminate the burden for infusion centers, reduce costs, and expand access to essentially any patient anywhere in the US, resulting in improved patient well-being and quality of life.
