Feasibility of a novel wearable thermal device for management of bothersome hot flashes in patients with prostate cancer

Background: This single-arm prospective study evaluated the feasibility of a novel wrist-worn thermal device that applies cooling to the inside of the wrist for management of bothersome hot flashes in prostate cancer survivors.Methods: 57 individuals were enrolled and instructed to use the thermal device as needed for management of hot flashes for 4 weeks. The primary outcome was thermal device usage (hours and sessions per day). Additional outcomes included the change in Hot Flash Related Daily Interference Scale (HFRDIS, range 0-10) and Patient Reported Outcomes Measurement Information System Sleep Disturbance 4a (PROMIS SD T-score, range 0-100) and Sleep-Related Impairment 8a (PROMIS SRI T-score, range 0-100). Study procedures were conducted remotely from May to Dec 2021 in the US.Results: 44 participants completed the study and 39 had retrievable usage data. The mean +/- SD age was 67 +/- 6 years and 5 +/- 5 years since cancer diagnosis. The baseline mean +/- SD HFRDIS score of 4.3 +/- 2.0 indicated moderate hot flash interference in this population. During the study, participants used the thermal device (mean +/- SD) 3.2 +/- 2.5 hours/day and 7.6 +/- 3.6 sessions/day. Most (67%) participants reported using the device 7 days and 7 nights each week. Statistically significant improvements from baseline at Week 4 were observed for HFRDIS (mean +/- SE change: -1.1 +/- 0.3), PROMIS SD (-6.0 +/- 1.0), and PROMIS SRI (-5.5 +/- 1.2) scores (all p < 0.001). The majority (69%) of participants reported that the thermal device was effective at helping them manage hot flashes. No adverse events were reported.Conclusions: Results support the feasibility of using the thermal device for management of bothersome hot flashes in prostate cancer survivors. Future randomized controlled studies are warranted to evaluate the impact of the thermal device on frequency and severity of hot flashes, sleep quality, fatigue, and overall quality of life.