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

The Ohio State University

Status: Completed

Conditions: Breast Ductal Carcinoma In Situ; Hot Flashes; Breast Carcinoma; Breast Lobular Carcinoma In Situ

Treatments: Device: EMBr Wave; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05086705

NCI-2019-05843 (Registry Identifier)

OSU-19152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm A (EMBr Wave)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Device: EMBr Wave

Arm B (crossover)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Device: EMBr Wave