Clinical trial · Interventional
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Breast Lobular Carcinoma In Situ | Breast Lobular Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMBr Wave | Device | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (EMBr Wave)
- description
- Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.
- interventionNames
- Device: EMBr Wave
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm B (crossover)
- description
- Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.
- interventionNames
- Device: EMBr Wave
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Device Usage
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Ability to provide informed written consent * Life expectancy \>= 6 months 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) * Prior use of EMBr Wave * Nickel allergy * Pregnant or nursing women since the safety of device has not been established in this population
References
Publications (0)
Data not yet available