Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT05086705
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05086705
Study Brief:
Protocol Section:
NCT05086705