![]() These modes allow you to select the type and duration of temperature waves you want to get the most user-centric experience out of the Embr Wave. ![]() There are 5 preset modes available on the application: Quick, Essential, Extended, Fall Asleep and Custom. In the middle of the dial, the current temperature of the Embr Wave is displayed along with a 'Stop' option in case you find the temperature change to be a little too overwhelming. The first thing you'll see when you open the app is a virtual dial to adjust the temperature of the Embr Wave, similar to a thermostat control panel. The app is designed to be user-friendly such that even non-tech savvy users will find it easy to use. ![]() Antineoplastic chemotherapy (anti-HER2 agents allowed) (current or planned therapy) – Androgens (current or planned therapy) – Systemic estrogens.The Embr Wave is compatible with the companion Embr Wave Application available on both iOS and Android.Women with history of breast cancer, ductal breast carcinoma in situ (DCIS), or lobular breast carcinoma in situ (LCIS) (currently without evidence of malignant disease) – Bothersome hot flashes (defined by their occurrence of >= 28 times per week and of sufficient severity to prompt the patient to seek therapeutic intervention) – Presence of hot flashes for > 30 days prior to study entry – Ability to complete questionnaire(s) by themselves or with assistance – Willingness to wear EMBr Wave device during the study period – Willingness to use the EMBr Wave mobile application – Have a working smartphone that can download the EMBr Wave mobile application (iPhone 6 or more recent generation, Android 8.0 or more recent generation) – Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1 – Ability to provide informed written consent – Life expectancy >= 6 months Exclusion Criteria:.Participating in This Clinical Trial Inclusion Criteria Reported via patient reported outcomes, primarily Hot Flash-Related Daily Interference Scale.The mean patient satisfaction scores for each Likert-type question and proportion of patients reporting satisfaction scores at or above 7 will be estimated in the entire sample and compared between sequence groups at the 5% significance level (two-sided).Rated on a 10-point Likert scale with 10 being most satisfied or most effective. Feasibility will be evaluated secondarily with respect to patient satisfaction.The proportion of patients who wear the device for at least 8 hours between 8:00 am and 8:00 pm for at least 22 days will be estimated using the entire sample and a 95% Jeffreys interval for binomial proportions will be computed. Feasibility will be evaluated primarily with respect to device usage.Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.Ĭlinical Trial Outcome Measures Primary Measures.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. ARM A: Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks. OUTLINE: Patients are randomized to 1 of 2 arms. To estimate effect sizes to inform power calculations for a future phase III trial. 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. To evaluate the preliminary efficacy of EMBr Wave in reducing hot flash severity and frequency in women with a history of breast cancer. To evaluate the feasibility of using EMBr Wave technology in women with a history of breast cancer who are experiencing bothersome hot flashes. Study Primary Completion Date: December 31, 2021.Intervention Model: Crossover Assignment.EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.įull Title of Study: “Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer” Study Type EMBr Wave is a personal heating and cooling device worn on the wrist. 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. Hot flashes are a common symptom experienced by menopausal women. This trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Overall Status: Recruiting | Estimated Enrollment: 30 Overview ![]() First Received: Octo| Last Updated: October 21, 2021
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