Status:
COMPLETED
Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer
Lead Sponsor:
University of Minnesota
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Breast cancer is the second most common cancer in women. One in five women who have been treated for breast cancer develop lymphedema. Lymphedema is a very common result of breast cancer and its treat...
Eligibility Criteria
Inclusion
- Adults 18 and over who are diagnosed with unilateral breast cancer.
- Unilateral lumpectomy, unilateral mastectomy, or simultaneous contralateral prophylatic mastectomy within 12 months of enrollment
- Axillary lymph node dissection or sentinel node biopsy within 12 months of enrollment
- Adjuvant or neoadjuvant chemotherapy and/or radiation therapy are allowed
- Breast cancer reconstruction completed or planned is allowed
- Study participants must own or have access to a smartphone, iPhone (IOS version 9.0 or above) or Android phone (Android 8.1 or above).
Exclusion
- Bilateral breast cancer
- Previous history of breast cancer prior to current diagnosis.
- Existing diagnosis of lymphedema at the time of enrollment
- Cellulitis or other active infection at the time of enrollment
- Adults who are unable to consent.
- Pregnant women
- Prisoners
- Individuals under the age of 18 years old
- Individuals who are illiterate
- Individuals who lack the capacity to consent
- Non-English speakers
- Individuals with medical implant devices such as pacemakers, or essential support devices such as patient monitoring systems.
Key Trial Info
Start Date :
June 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06580743
Start Date
June 12 2024
End Date
September 30 2025
Last Update
October 1 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414