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TOPLINE:

A novel wrist cooling device produced a 46% reduction in severe hot flash episodes in patients with prostate or breast cancer undergoing hormone deprivation therapy and in postmenopausal women, with no adverse events reported.

METHODOLOGY:

• Hot flashes significantly affect quality of life in patients undergoing hormone deprivation therapy for cancer and in postmenopausal women, with pharmaceutical interventions often carrying substantial risks.
• Researchers evaluated whether the novel wrist cooling device KÜLKUF could serve as a safe, nonpharmaceutical intervention to reduce hot flash severity in a crossover clinical trial with 27 participants (10 women with breast cancer, 12 men with prostate cancer, and five postmenopausal women) experiencing at least two moderate-to-severe daily hot flashes.
• Participants were randomly assigned to receive either the active KÜLKUF wrist cooling device (cooling to 47°F via a porcelain plate in direct contact with the skin) or an identical sham device (fan only) for 2 weeks, followed by crossover to the alternative device for 2 additional weeks.
• The frequency and severity of hot flashes were recorded in standardized diaries for 2 weeks before any device was used and again during the two separate 2-week periods of device use.
• The primary endpoint was a reduction in severe hot flash episodes from baseline, and secondary outcomes included total daily hot flash frequency.

TAKEAWAY:

• The active cooling intervention reduced severe hot flash episodes by 46% (95% CI, 18%-74%) and total daily hot flashes by 18% (95% CI, 2%-34%) from baseline; in contrast, the sham device led to minimal reduction in symptoms.
• Subgroup analysis revealed consistent effects across populations: a 41% reduction in patients with breast cancer, and a 50% reduction in both postmenopausal women and patients with prostate cancer.
• The benefits of the cooling device persisted even after adjusting for age and underlying conditions.
• No adverse events were reported, and adherence to the protocol was high, indicating that the device was comfortable for regular use.

IN PRACTICE:

“KÜLKUF offers several distinct advantages compared to other nonpharmaceutical interventions, including yoga and acupuncture, which on review were not recognized as being effective nor recommended by The North American Menopause Society,” the authors wrote.

“Whereas hormone replacement therapy can take several days to several weeks for some women to achieve its maximum benefit in controlling VMS [vasomotor symptoms], KÜLKUF can induce almost immediately an effect that can be initiated every time the patient is beginning to experience the initiation of a hot flash/VMS,” they added.

SOURCE:

This study was led by Nazlı Uçar, MS, Department of Medicine, Boston University, Chobanian & Avedisian School of Medicine in Boston. It was published online in AACE Endocrinology and Diabetes.

LIMITATIONS:

The pilot study was significantly underpowered to detect the observed effect size for the primary outcome. True double-blinding proved impossible due to the perceptible cooling sensation of the active device. The brief 2-week study duration per treatment phase was insufficient to assess long-term efficacy or potential adaptation effects.

DISCLOSURES:

This study was supported by institutional resources. The authors reported having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.