Breast Carcinoma Clinical Trial
Official title:
Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer
Verified date | September 2023 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 24, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center | Embr Labs, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device usage | 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. | Up to 8 weeks | |
Primary | Patient satisfaction | 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 effective. | Up to 8 weeks | |
Secondary | Effect of EMBr Wave using Hot Flash-Related Daily Interference Scale (HFRDIS) | Reported via patient reported outcomes, primarily Hot Flash-Related Daily Interference Scale (HFRDIS), a scale of 0-10 with 0 being no interference (best outcome) and 10 being completely interfere (worst outcome). Survey administered on paper or via RedCap survey distribution at baseline. | Up to 8 weeks |
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