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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05843 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Embr Labs, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (EMBr Wave) | Experimental | Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks. |
|
| Arm B (crossover) | Active Comparator | Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMBr Wave | Device | Use EMBr Wave |
| |
| 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. | At 8 weeks |
| 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 week 4 and week 8. | At week 4 and at week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sagar Sardesai, MBBS | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Arm B (EMBr Wave Second) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was not collected or analyzed | Posted | Up to 8 weeks |
|
Adverse event data was collected over the study duration; a total 8 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMBr Wave Device | Participants utilized the EMBr wave device for 4 weeks. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sagar Sardesai | The Ohio State University Comprehensive Cancer Center | 614-293-6401 | sagar.sardesai@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2023 | May 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2022 | May 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Questionnaire Administration |
| Other |
Ancillary studies |
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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
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | 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 | Posted | Mean | Full Range | score on a scale | At 8 weeks |
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| Secondary | 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 week 4 and week 8. | Posted | Mean | Standard Error | units on a scale | At week 4 and at week 8 |
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| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | No Treatment | Patients received no treatment for 4 weeks. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Social |
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| Leisure |
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| Sleep |
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| Mood |
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| Concentrate |
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| Relation |
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| Sexuality |
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| Enjoy |
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| Quality |
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| Worth |
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| Satisfy |
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| Leisure Activities |
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| Sleep |
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| Mood |
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| Concentration |
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| Relations with others |
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| Sexuality |
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| Enjoyment of Life |
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| Quality of Life |
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