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

Primary Purpose

Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMBr Wave
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (EMBr Wave)

Arm B (crossover)

Arm Description

Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.

Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 8, 2021
Last Updated
September 9, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
Embr Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05086705
Brief Title
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
Official Title
Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
August 24, 2023 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
Embr Labs, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Hot Flashes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (EMBr Wave)
Arm Type
Experimental
Arm Description
Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.
Arm Title
Arm B (crossover)
Arm Type
Active Comparator
Arm Description
Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.
Intervention Type
Device
Intervention Name(s)
EMBr Wave
Intervention Description
Use EMBr Wave
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Device usage
Description
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.
Time Frame
Up to 8 weeks
Title
Patient satisfaction
Description
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.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Effect of EMBr Wave using Hot Flash-Related Daily Interference Scale (HFRDIS)
Description
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.
Time Frame
Up to 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sagar Sardesai, MBBS
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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