Randomized Controlled Cross-over Study for Hot Flash Management: Efficacy Novel Wrist Cooling Device in Cancer Treatment-Induced and Menopausal Vasomotor Symptoms

Hot flashes significantly impact quality of life in cancer patients undergoing hormone deprivation therapy and postmenopausal women. Pharmaceutical interventions often carry substantial risks. This double-blind randomized crossover trial evaluated the efficacy of KÜLKUF, a wrist-mounted cooling device that rapidly delivers a 47°F cooling stimulus upon activation, in 27 participants (n = 10 breast cancer, n = 12 prostate cancer, n = 5 postmenopausal women) experiencing at least two moderate-to-severe hot flashes daily. Compared to baseline measurements, the active cooling intervention reduced severe hot flash episodes by 46% (p < 0.02) and total daily hot flashes by 18%. Subgroup analysis revealed consistent therapeutic effects across all participant categories, with severe hot flash reductions of 41% in breast cancer patients and 50% in both postmenopausal women and prostate cancer patients. Univariate analysis adjusted for age and underlying condition confirmed a significant reduction in hot flash severity (p < 0.01). The crossover design, which achieved perfect retention with no dropouts, allowed participants to serve as their own controls, enhancing statistical power despite the modest sample size. No adverse events or tolerability issues were reported throughout the study period. These findings suggest that targeted peripheral thermosensory input via wrist cooling represents a promising non-pharmaceutical approach for managing vasomotor symptoms across diverse patient populations.