EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hot Flashes; Breast Carcinoma; Breast Ductal Carcinoma In Situ; Breast Lobular Carcinoma In Situ
• Intervention / Treatment: Other: Questionnaire Administration; Device: EMBr Wave

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (EMBr Wave); Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.	Other: Questionnaire Administration; Ancillary studies; Device: EMBr Wave; Use EMBr Wave
Active Comparator: Arm B (crossover); Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.	Other: Questionnaire Administration; Ancillary studies; Device: EMBr Wave; Use EMBr Wave

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Embr Labs, Inc.
• Investigators: Principal Investigator: Sagar Sardesai, MBBS, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): August 24, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ; Breast Neoplasms; Carcinoma; Breast Carcinoma In Situ; Hot Flashes; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Carcinoma, Ductal, Breast
• Other Study ID Numbers: OSU-19152; NCI-2019-05843 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes