Breast CarcinomaNCT05086705
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
A study testing EMBr Wave and Questionnaire Administration in people with Breast Carcinoma and Breast Ductal Carcinoma In Situ, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ
- What is being tested?
- EMBr Wave and Questionnaire Administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2020to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of using EMBr Wave technology in women with a history of breast cancer who are experiencing bothersome hot flashes.
SECONDARY OBJECTIVES:
- To evaluate the preliminary efficacy of EMBr Wave in reducing hot flash severity and frequency in women with a history of breast cancer.
II. To identify in what ways EMBr Wave has the greatest potential efficacy, such as reduction in vasomotor symptoms (VMS) severity, frequency, duration, sense of control, or self-esteem.
III. To estimate effect sizes to inform power calculations for a future phase III trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.
ARM B: Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.
- Conditions
- Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Hot Flashes
- Being tested
- EMBr Wave, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMBr WaveDevice
Use EMBr Wave
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (EMBr Wave) | Experimental | Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks. Receives: Device: EMBr Wave; Other: Questionnaire Administration |
| Arm B (crossover) | Active comparator | Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks. Receives: Device: EMBr Wave; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks
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.
Measured: At 8 weeks
Secondary outcomes (1)
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 week 4 and week 8.
Measured: At week 4 and at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start7 Oct 2020
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Embr Labs, Inc.
- Responsible party
- Principal investigator, Sagar Sardesai, Ohio State University Comprehensive Cancer Center
- Investigators
- Sagar Sardesai, MBBS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086705
- Sponsor's protocol ID
- OSU-19152
- Other IDs
- NCI-2019-05843
- Status last verified
- Apr 2025
- First submitted
- 8 Oct 2021
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer
- ClinicalTrials.gov ID
- NCT05086705
- Acronym / sponsor ID
- OSU-19152
- Conditions
- Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Hot Flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Embr Labs, Inc.
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Posted 22 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of using EMBr Wave technology in women with a history of breast cancer who are experiencing bothersome hot flashes.
SECONDARY OBJECTIVES:
- To evaluate the preliminary efficacy of EMBr Wave in reducing hot flash severity and frequency in women with a history of breast cancer.
II. To identify in what ways EMBr Wave has the greatest potential efficacy, such as reduction in vasomotor symptoms (VMS) severity, frequency, duration, sense of control, or self-esteem.
III. To estimate effect sizes to inform power calculations for a future phase III trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.
ARM B: Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (EMBr Wave) | Experimental | Device: EMBr Wave, Other: Questionnaire AdministrationPatients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks. |
| Arm B (crossover) | Active comparator | Device: EMBr Wave, Other: Questionnaire AdministrationPatients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMBr WaveUse EMBr Wave | Device | Arm A (EMBr Wave), Arm B (crossover) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (EMBr Wave), Arm B (crossover) |
Primary outcome
Device Usage
Time frame: Up to 8 weeks
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.
Patient Satisfaction
Time frame: At 8 weeks
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.
1 secondary outcome
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Time frame: At week 4 and at week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sagar Sardesai, MBBS principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMBr Wave and Questionnaire Administration in people with Breast Carcinoma and Breast Ductal Carcinoma In Situ, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Usage (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.