What is the mechanism of action of this treatment?

Hot flashes are commonly treated with hormone therapy, which works by supplementing estrogen to stabilize the body's thermoregulatory center in the hypothalamus. Nonhormonal treatments, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), modulate neurotransmitters to help regulate body temperature. The EMBr Wave device, a nonhormonal option, uses thermal regulation by providing controlled heating and cooling sensations to the wrist, which can help manage the body's perception of temperature changes. This is particularly important for patients who cannot use hormone therapy due to contraindications, such as a history of breast cancer, offering them a safe and effective alternative for managing hot flashes.

What side effects are associated with this type of intervention?

Common treatments for hot flashes that involve thermal regulation, such as the EMBr Wave device, include personal heating and cooling devices and scalp cooling systems. Known side effects of these treatments can include mild headache, scalp pain, feeling cold, neck pain, and a sensation of heaviness in the head. These side effects are generally minimal to modest and are often well-tolerated by patients.

What prior FDA approvals exist?

FDA-approved treatments for hot flashes primarily include hormone replacement therapy (HRT) such as estradiol transdermal systems and other medications like esmirtazapine. These treatments focus on alleviating vasomotor symptoms through hormonal or pharmacological means. While the EMBr Wave device, which uses thermal regulation, is being studied for its efficacy in reducing hot flashes, there is no specific mention of FDA-approved thermal regulation devices for this purpose in the provided context.

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Behavioural Intervention

EMBr Wave Device for Hot Flashes in Breast Cancer Survivors

Q: What other types of research exist?

Promising alternatives to EMBr Wave for managing hot flashes in 2024 include: 1) Cognitive Behavioral Therapy (CBT), which has shown effectiveness in reducing menopausal symptoms, including hot flashes. 2) Non-hormonal pharmacological options such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which are effective in reducing hot flash frequency and severity. 3) Scalp hypothermia, which, while primarily used for chemotherapy-induced alopecia, may offer some thermal regulation benefits. These alternatives provide non-hormonal options suitable for patients with a history of breast cancer.

N/A

Waitlist Available

Led By Sagar Sardesai, MBBS

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Presence of hot flashes for > 30 days prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed for this trial; however, since it involves wearing a non-invasive device on the wrist, risks may be minimal compared to drug therapies. Users should monitor for any skin irritation or discomfort due to wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been experiencing hot flashes for more than 30 days.

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I am fully active or have some restrictions but can still care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Device usage

Patient satisfaction

Secondary study objectives

Effect of EMBr Wave using Hot Flash-Related Daily Interference Scale (HFRDIS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (EMBr Wave)Experimental Treatment2 Interventions

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

Group II: Arm B (crossover)Active Control2 Interventions

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hot flashes are commonly treated with hormone therapy, which works by supplementing estrogen to stabilize the body's thermoregulatory center in the hypothalamus. Nonhormonal treatments, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), modulate neurotransmitters to help regulate body temperature. The EMBr Wave device, a nonhormonal option, uses thermal regulation by providing controlled heating and cooling sensations to the wrist, which can help manage the body's perception of temperature changes. This is particularly important for patients who cannot use hormone therapy due to contraindications, such as a history of breast cancer, offering them a safe and effective alternative for managing hot flashes.

Is placebo as effective as estrogen regimens on vasomotor symptoms in women with surgical menopause?Vasomotor symptoms in menopause: physiologic condition and central nervous system approaches to treatment.Estrogen with and without progestin: benefits and risks of short-term use.