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

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.