"This study, using a novel technology to manage hot flashes, truly moves the field forward in improving the quality of life for men with prostate cancer,” says Alicia K. Morgans, MD, MPH.
A recent study published in Prostate Cancer and Prostatic Diseases shows the feasibility of a wearable thermal device for the management of hot flashes due to treatment for prostate cancer.1
No adverse events with the device were reported.
The device works by using a thermoelectric heat pump to provide either heating or cooling to participants’ wrists upon activation.
"During treatment for prostate cancer, there are many complications we consider when we think about how to optimize survivorship. This study, using a novel technology to manage hot flashes, truly moves the field forward in improving the quality of life for men with prostate cancer,” said Alicia K. Morgans, MD, MPH, in a news release on the findings.2 Morgans is the medical director of the survivorship program at Dana-Farber Cancer Institute in Boston, Massachusetts.
Overall, 44 patients completed the 4-week prospective study, and 39 had retrievable device usage data for analysis. The average age of participants was 67 years. The primary outcome was device usage, indicated by hours and sessions of use per day. Investigators also measured Hot Flash Related Daily Interference Scale scores (HFRDIS, range 0-10), Patient Reported Outcomes Measurement Information System Sleep Disturbance scores (PROMIS SD T-score, range 0-100), Sleep-Related Impairment scores (PROMIS SRI T-Score, range 0-100), and patient-reported outcome measures as secondary outcome measures.
On average, participants used the device for 3.2 (SD, 2.5) hours per day for 7.6 (SD, 3.6) sessions per day. Among all participants, 67% reported using the device 7 days and 7 nights each week. Although the device could provide heating and cooling, all participants used the device exclusively for cooling.
Across all secondary measures analyzed, the investigators observed statistically significant changes from baseline to week 4. At baseline, the average HFRDIS score was 4.3 (SD, 2.0), indicating moderate hot flash interference. At 4 weeks, an average decrease of 1.1 (SD, 0.3) was observed in HFRDIS (P < .001). Reductions in all HFRDIS items of hot flash interference were also observed, which included sleep, overall quality of life, enjoyment of life, concentration, mood, leisure activities, work, social activities, and social relations (P < .05).
At baseline, the average PROMIS SD and SRI scores were 56 (SD, 7) and 57 (SD, 10), respectively. An average decrease of 6.0 (SD, 1.0) in PROMIS SD and 5.5 (SD, 1.2) in PROMIS SRI (both P < .001) were reported.
Regarding patient reported outcome measures, most participants (69%) indicated that the device was effective in helping them manage their hot flashes, and 77% reported being somewhat to very satisfied with the device. Overall, statistically significant differences from baseline to week 4 were observed in the patient reported outcomes of hot flash number, bother, interference with daily life or sleep, and control over interference from hot flashes.
No adverse events with the device were reported.
Based on these findings, the authors note that further randomized controlled studies of the device are needed.
References
1. Peeke P, Billes SK, Vetter A, Naghavi N, Le D, Smith M, Morgans AK. Feasibility of a novel wearable thermal device for management of bothersome hot flashes in patients with prostate cancer. Prostate Cancer Prostatic Dis. 2023. doi:10.1038/s41391-023-00771-2
2. Embr Labs announces publication of groundbreaking study on hot flashes in prostate cancer patients in prestigious Nature journal. News release. Embr Labs. December 21, 2023. Accessed December 22, 2023. https://www.prnewswire.com/news-releases/embr-labs-announces-publication-of-groundbreaking-study-on-hot-flashes-in-prostate-cancer-patients-in-prestigious-nature-journal-302020590.html
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