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Behavioural Intervention

EMBr Wave Device for Hot Flashes in Breast Cancer Survivors

N/A
Waitlist Available
Led By Sagar Sardesai, MBBS
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Presence of hot flashes for > 30 days prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights

Study Summary

This trial studies a device to reduce hot flashes in menopausal women with a history of breast cancer, who can't use hormone replacement therapy.

Who is the study for?
This trial is for women with a history of breast cancer who experience frequent hot flashes (at least 28 times per week) and are not currently undergoing certain cancer treatments. Participants must be willing to wear the EMBr Wave device, use its mobile app, have a smartphone compatible with the app, and have an ECOG performance status of 0 or 1.Check my eligibility
What is being tested?
The study tests if the EMBr Wave device can reduce hot flash severity in women who've had breast cancer. The wearable tech aims to provide relief without hormones by heating or cooling at the wrist. Participants will also complete questionnaires about their experiences.See study design
What are the potential side effects?
Potential side effects are not detailed for this trial; however, since it involves wearing a non-invasive device on the wrist, risks may be minimal compared to drug therapies. Users should monitor for any skin irritation or discomfort due to wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had breast cancer or a non-invasive breast condition but currently show no signs of cancer.
Select...
I have been experiencing hot flashes for more than 30 days.
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I am fully active or have some restrictions but can still care for myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device usage
Patient satisfaction
Secondary outcome measures
Effect of EMBr Wave using Hot Flash-Related Daily Interference Scale (HFRDIS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (EMBr Wave)Experimental Treatment2 Interventions
Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.
Group II: Arm B (crossover)Active Control2 Interventions
Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,117 Total Patients Enrolled
Embr Labs, Inc.Industry Sponsor
2 Previous Clinical Trials
87 Total Patients Enrolled
1 Trials studying Hot Flashes
57 Patients Enrolled for Hot Flashes
Sagar Sardesai, MBBSPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials

Media Library

EMBr Wave (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05086705 — N/A
Hot Flashes Research Study Groups: Arm A (EMBr Wave), Arm B (crossover)
Hot Flashes Clinical Trial 2023: EMBr Wave Highlights & Side Effects. Trial Name: NCT05086705 — N/A
EMBr Wave (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05086705 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for prospective participants in this experiment?

"Affirmative. The clinicaltrials.gov website has information indicating that this research is on the hunt for participants as of now. This project was first posted in October 7th 2020, and its latest edit happened on October 20th 2021; currently they are recruiting 30 people from one trial centre."

Answered by AI

How many participants are included in this experiment?

"Affirmative. According to the records available on clinicaltrials.gov, this trial is presently looking for participants. It was initially listed on October 7th 2020 and has been modified most recently as of October 20th 2021. The study needs 30 patients from a single site to be recruited in total."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Ohio State University Comprehensive Cancer Center

Why did patients apply to this trial?

Hoping to find something to make the cancer fighting process easier.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
Sagar Sardesai 2020. "EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05086705.
All > Hot Flashes
~11 spots leftby Apr 2025
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