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

NCT05086705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-22

Study results available
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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.

Conditions

  • Breast Carcinoma
  • Breast Ductal Carcinoma In Situ
  • Breast Lobular Carcinoma In Situ
  • Hot Flashes

Interventions

DEVICE

EMBr Wave

Use EMBr Wave

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Embr Labs, Inc.

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Sagar Sardesai, MBBS · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2023-08-24
Completion
2023-08-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05086705 on ClinicalTrials.gov