Portable, Patient-Administered, Sensor-Enhanced Scalp Cooling Cap and Smartphone App to Reduce Provider Burden, Improve Patient Access, and Improve Patient Outcomes for Chemotherapy-induced Alopecia - PROJECT SUMMARY—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.
