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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04996316 -
MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
|
||
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Completed |
NCT05526872 -
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening
|
N/A | |
Not yet recruiting |
NCT05178498 -
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
|
||
Recruiting |
NCT05544123 -
The Treatment Situation of Chinese County Population With Breast Cancer
|
||
Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Recruiting |
NCT01462903 -
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
Completed |
NCT01422408 -
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
|
Phase 2 | |
Terminated |
NCT00770354 -
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
|
Phase 2 | |
Terminated |
NCT02810873 -
Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
|
N/A | |
Withdrawn |
NCT03185871 -
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
|
Phase 2 | |
Completed |
NCT02983279 -
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
|
N/A | |
Active, not recruiting |
NCT02194387 -
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
|
N/A | |
Recruiting |
NCT05406232 -
Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
|
||
Recruiting |
NCT03408353 -
Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
|
||
Completed |
NCT01641068 -
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
|
N/A | |
Withdrawn |
NCT04190433 -
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
|
Phase 2 | |
Recruiting |
NCT04799535 -
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
|
||
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |