Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT05086705
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2021-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-05843 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |