EMBr Wave Device for Hot Flashes in Breast Cancer Survivors

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Androgens, Systemic estrogens, Progestogens, Clonidine

Disqualifiers: Antineoplastic chemotherapy, Nickel allergy, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the EMBr Wave treatment for hot flashes in breast cancer survivors?

A study on a similar wearable thermal device for prostate cancer survivors showed it was feasible to manage hot flashes by applying cooling to the wrist, suggesting that the EMBr Wave, which likely uses a similar approach, could also help breast cancer survivors with hot flashes. ^{1 2 3 4 5}

Is the EMBr Wave Device safe for humans?

The EMBr Wave Device, a wrist-worn thermal device, was evaluated for safety in a study with prostate cancer survivors and was found to be feasible for managing hot flashes, suggesting it is generally safe for human use. ^{3 4 6 7 8}

How is the EMBr Wave treatment different from other treatments for hot flashes in breast cancer survivors?

The EMBr Wave device is unique because it is a wearable device that provides thermal sensations to help manage hot flashes, unlike traditional treatments that may involve medication. This approach offers a non-drug option for managing symptoms, which can be particularly beneficial for breast cancer survivors who may want to avoid additional medications. ^{1 2 3 7 8}

What is the purpose of this trial?

This trial studies how well the EMBr Wave device works in reducing hot flashes in women with a history of breast cancer. These women cannot use hormone replacement therapy, so the device offers an alternative by providing heating or cooling sensations on the wrist to manage hot flashes.

Research Team

Sagar Sardesai, MBBS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

Willingness to wear EMBr Wave device during the study period

I had breast cancer or a non-invasive breast condition but currently show no signs of cancer.

Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria

I am currently on, or plan to start, androgen therapy within 4 weeks.

You have used EMBr Wave before.

I am currently undergoing or planning to start chemotherapy within 4 weeks, but treatments targeting HER2 are okay.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants utilize the EMBr Wave device for 4 weeks, then crossover to no treatment for 4 weeks

8 weeks

2 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EMBr Wave

Trial Overview The study tests if the EMBr Wave device can reduce hot flash severity in women who've had breast cancer. The wearable tech aims to provide relief without hormones by heating or cooling at the wrist. Participants will also complete questionnaires about their experiences.

Participant Groups

Group I: Arm A (EMBr Wave) Experimental Treatment 2 Interventions

Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.

Group II: Arm B (crossover) Active Control 2 Interventions

Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Embr Labs, Inc.

Industry Sponsor

Trials

3

Recruited

130+

References

1. United States pubmed.ncbi.nlm.nih.gov

Hot flashes and related outcomes in breast cancer survivors and matched comparison women. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility and psychometrics of an ambulatory hot flash monitoring device. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility of a novel wearable thermal device for management of bothersome hot flashes in patients with prostate cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Hot flashes in breast cancer survivors. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Hot flashes and their management in breast cancer. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A pilot study of magnetic therapy for hot flashes after breast cancer. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Sternal skin conductance: a reasonable surrogate for hot flash measurement? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Validation of a sternal skin conductance criterion for measuring hot flashes in breast cancer patients. [2019]