NCT05086705

EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer

Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Hot flashes are a common symptom experienced by menopausal women. The standard treatment for hot flashes is hormone replacement therapy, however hormone replacement therapy cannot be used in women with a history of, or active, breast cancer. EMBr Wave is a personal heating and cooling device worn on the wrist. EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the feasibility of using EMBr Wave technology in women with a history of breast cancer who are experiencing bothersome hot flashes. SECONDARY OBJECTIVES: I. To evaluate the preliminary efficacy of EMBr Wave in reducing hot flash severity and frequency in women with a history of breast cancer. II. To identify in what ways EMBr Wave has the greatest potential efficacy, such as reduction in vasomotor symptoms (VMS) severity, frequency, duration, sense of control, or self-esteem. III. To estimate effect sizes to inform power calculations for a future phase III trial. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks. ARM B: Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.

Conditions

• Breast Carcinoma
• Breast Ductal Carcinoma In Situ
• Breast Lobular Carcinoma In Situ
• Hot Flashes

Interventions

Type	Name	Description
DEVICE	EMBr Wave	Use EMBr Wave
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-10-07
• Primary completion: 2023-08-24
• Completion: 2023-08-24
• First posted: 2021-10-21
• Last updated: 2025-04-22
• Results posted: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study