N/A
N=50
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
Breast Carcinoma · Breast Ductal Carcinoma In Situ · Breast Lobular Carcinoma In Situ · Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT05086705 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Device Usage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EMBr Wave (Device); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Usage |
— | — |
| PRIMARY Patient Satisfaction |
4.97; 5.48; 4.76; 4.72; 4.86; 4.41 | — |
| SECONDARY Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) |
3.6368; 3.6743; 3.0626; 3.1652; 3.4362; 3.5256 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05086705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.