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

What this trial studies

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.

Conditions in scope

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

Interventions

• EMBr Wave (Device) — Use EMBr Wave
• Questionnaire Administration (Other) — Ancillary studies

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• 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

Exclusion criteria

• Antineoplastic chemotherapy (anti-HER2 agents allowed) (current \[=\< 4 weeks prior\] or planned therapy)
• Androgens (current \[=\< 4 weeks prior\] or planned therapy)
• Systemic estrogens. Local vaginal estrogen preparations are allowed, but need to have been initiated for vulvo-vaginal atrophy at least 28 days prior, and must not be expected to stop or change the dose or frequency of the medication during the study period (current \[=\< 4 weeks prior\] or planned therapy)
• Progestogens (current \[=\< 4 weeks prior\] or planned therapy)
• Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period (current \[=\< 4 weeks prior\] or planned therapy)
• Selective serotonin reuptate inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitor (SNRIs), when being used for hot flash management or other indications such as depression, is allowed, assuming the dose will remain unchanged for the study duration (current \[=\< 4 weeks prior\] or planned therapy)
• Gabapentin/pregabalin, when being used for hot flash management (use for other indications, such as pain, is allowed, assuming the dose will remain unchanged for the study duration) (current \[=\< 4 weeks prior\] or planned therapy)
• Clonidine (current \[=\< 4 weeks prior\] or planned therapy)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2020-10-07
• Primary completion: 2023-08-24
• Last update posted: 2025-04-22
• First posted: 2021-10-21

Sponsor & contact

Lead sponsor: Ohio State University Comprehensive Cancer Center (Other)

Collaborators: Embr Labs, Inc.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Device Usage (Up to 8 weeks)
  Feasibility will be evaluated primarily with respect to device usage. 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.
• Patient Satisfaction (At 8 weeks)
  Feasibility will be evaluated secondarily with respect to patient satisfaction. 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…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.