EMBr Wave Device for Hot Flashes in Breast Cancer Survivors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the EMBr Wave device can reduce hot flashes in women who have had breast cancer. Worn on the wrist, the device uses heating and cooling to potentially ease these symptoms. Participants will use the device for four weeks, followed by four weeks without it, to assess its effectiveness. Women who have had breast cancer and experience frequent, bothersome hot flashes may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance symptom management for many women.
Will I have to stop taking my current medications?
You may need to stop certain medications like antineoplastic chemotherapy, androgens, systemic estrogens, progestogens, and clonidine if you are currently taking them or plan to start them soon. However, medications like tamoxifen, raloxifene, aromatase inhibitors, SSRIs, SNRIs, gabapentin, and pregabalin can be continued if the dose remains unchanged during the study.
What prior data suggests that the EMBr Wave device is safe for breast cancer survivors?
Research has shown that the EMBr Wave device is generally easy to use and safe. This wearable gadget, which can cool or warm the wrist, is designed to help reduce hot flashes. It feels similar to holding a warm mug or a cold glass, making it safe and non-invasive, with no reports of serious side effects.
Most people find it helpful for managing hot flashes and night sweats, using it both day and night to control their symptoms. Overall, the device appears to be a safe choice for those seeking non-drug relief from hot flashes.12345Why are researchers excited about this trial?
Unlike the standard treatments for hot flashes, such as hormone replacement therapy and certain antidepressants, the EMBr Wave device offers a drug-free solution. This wearable device provides personalized temperature control, which can help manage hot flashes by cooling the skin. Researchers are excited because this approach offers a non-invasive, immediate way to alleviate symptoms without the side effects associated with medications.
What evidence suggests that the EMBr Wave device is effective for reducing hot flashes in breast cancer survivors?
Research has shown that the EMBr Wave device can help reduce hot flashes in women who have had breast cancer. In this trial, participants in Arm A will use the EMBr Wave device for 4 weeks. One study found that women using the device reported 28% fewer hot flashes each day and experienced a 50% reduction in moderate to severe hot flashes. Most users (69%) found the device helpful for managing their symptoms, and no side effects were reported. This evidence suggests that the EMBr Wave could be a good option for those unable to use hormone replacement therapy.36789
Who Is on the Research Team?
Sagar Sardesai, MBBS
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for women with a history of breast cancer who experience frequent hot flashes (at least 28 times per week) and are not currently undergoing certain cancer treatments. Participants must be willing to wear the EMBr Wave device, use its mobile app, have a smartphone compatible with the app, and have an ECOG performance status of 0 or 1.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants utilize the EMBr Wave device for 4 weeks, then crossover to no treatment for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EMBr Wave
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Embr Labs, Inc.
Industry Sponsor