Trial Outcomes & Findings for EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer (NCT NCT05086705)
NCT ID: NCT05086705
Last Updated: 2025-04-22
Results Overview
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.
COMPLETED
NA
50 participants
Up to 8 weeks
2025-04-22
Participant Flow
Participant milestones
| Measure |
Arm A (EMBr Wave First)
Patients utilize the EMBr Wave device for 4 weeks, then receive no treatment for 4 weeks.
EMBr Wave: Use EMBr Wave
Questionnaire Administration: Ancillary studies
|
Arm B (EMBr Wave Second)
Patients receive no treatment for 4 weeks, then utilize the EMBr Wave Device for 4 weeks.
EMBr Wave: Use EMBr Wave
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A (EMBr Wave First)
n=25 Participants
Patients utilize the EMBr Wave device for 4 weeks, then receive no treatment for 4 weeks.
EMBr Wave: Use EMBr Wave
Questionnaire Administration: Ancillary studies
|
Arm B (EMBr Wave Second)
n=25 Participants
Patients receive no treatment for 4 weeks, then utilize the EMBr Wave device for 4 weeks.
EMBr Wave: Use EMBr Wave
Questionnaire Administration: Ancillary studies
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Data was not collected or analyzed
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 8 weeksPopulation: Patient satisfaction data was only obtained for the 29 out of 50 participants who gave responses for the exit survey (12 from Arm A and 17 from Arm B). Satisfaction scores pertain to satisfaction with EMBr wave device usage, so no data is reported for the No Treatment Group
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.
Outcome measures
| Measure |
EMBr Wave Device
n=29 Participants
Participants utilized the EMBr wave device for 4 weeks.
|
No Treatment
Patients received no treatment for 4 weeks.
|
|---|---|---|
|
Patient Satisfaction
Duration
|
5.48 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Work
|
4.76 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Social
|
4.72 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Leisure
|
4.86 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Sleep
|
4.41 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Mood
|
4.97 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Concentrate
|
4.90 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Relation
|
4.41 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Sexuality
|
3.24 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Enjoy
|
5.10 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Quality
|
5.38 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Worth
|
5.79 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Satisfy
|
5.52 score on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient Satisfaction
Intensity
|
4.97 score on a scale
Interval 0.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: At week 4 and at week 8Reported 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.
Outcome measures
| Measure |
EMBr Wave Device
n=50 Participants
Participants utilized the EMBr wave device for 4 weeks.
|
No Treatment
n=50 Participants
Patients received no treatment for 4 weeks.
|
|---|---|---|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Enjoyment of Life
|
3.2259 units on a scale
Standard Error 0.3234
|
3.3231 units on a scale
Standard Error 0.3651
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Work
|
3.6368 units on a scale
Standard Error 0.3386
|
3.6743 units on a scale
Standard Error 0.3261
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Social Activities
|
3.0626 units on a scale
Standard Error 0.3356
|
3.1652 units on a scale
Standard Error 0.3590
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Leisure Activities
|
3.4362 units on a scale
Standard Error 0.3063
|
3.5256 units on a scale
Standard Error 0.3566
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Sleep
|
4.8231 units on a scale
Standard Error 0.3948
|
5.4950 units on a scale
Standard Error 0.3403
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Mood
|
3.7743 units on a scale
Standard Error 0.3367
|
4.0794 units on a scale
Standard Error 0.3254
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Concentration
|
3.7391 units on a scale
Standard Error 0.3464
|
4.1341 units on a scale
Standard Error 0.3634
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Relations with others
|
2.5774 units on a scale
Standard Error 0.3331
|
2.6717 units on a scale
Standard Error 0.3520
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Sexuality
|
2.9739 units on a scale
Standard Error 0.4058
|
3.1144 units on a scale
Standard Error 0.4228
|
|
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Quality of Life
|
3.4489 units on a scale
Standard Error 0.3248
|
3.5543 units on a scale
Standard Error 0.3386
|
Adverse Events
EMBr Wave Device
No Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sagar Sardesai
The Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place