Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer
NCT Number: NCT06580743
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Interventions: OTHER: No intervention
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-12
Completion Date: 2025-10-01
Locations: University of Minnesota, Minneapolis, Minnesota, 55414, United States

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 treatment. Lymphedema is the build-up of fluid in tissues, which results in tissue swelling. The lymph system is a network of lymph vessels, tissues, and organs that carry extra fluid from your cells/tissues throughout the body. If this lymph fluid is not able to flow in the body how it should, there will be swelling which can lead to lymphedema. It can be classified into stages 0 to 3 depending on the severity of the condition. Stages 0 and 1 are reversible, and through early diagnosis and treatment, the recovery to the normal volume and normal skin status of arms can be possible. On the other hand, stage 2 or higher is irreversible, and tissue fibrosis progresses and cannot return to normal skin; therefore, it is important to detect early and start treatment.

This is an observational longitudinal study. Potential participants will be recruited for follow-up after breast cancer surgery. Only patients who fit the inclusion criteria will be considered for participation in the study and contacted by the healthcare provider. Standard of care will be used to guide any treatment needed by participants while they are part of the study.

Primary Outcome Measures: Measurement of impedances and extracellular water (ECW) ratio, Measurement of impedances and extracellular water (ECW) ratio between affected and unaffected sides at initial visit using the clinical and home units (InBody 770 and InBody BWA ON).

Inbody BWA 770 Timeline: baseline, 3, 6, 9, 12 month Inbody BWA ON Timeline: 2x/day x 12 months, 3, 6, 9, and 12 months
Secondary Outcome Measures: Measurement of impedances and extracellular water (ECW) ratio, Measurement of impedances and extracellular water (ECW) ratio between affected and unaffected sides at 3, 6, 9, and 12 months using the clinical and home units., 3, 6, 9, and 12 months|attitudes, Measure qualitative responses through exit interviews with participants to learn their attitudes toward their evaluation with the home BIA home device at 12 months., 12 months|Bilateral upper extremity shoulder goniometric range of motion measurements, measured in degrees, baseline, 3, 6, 9, and 12 months|Bilateral upper extremity girth circumference measurements, measured in centimeters, baseline, 3, 6, 9, and 12 months|Impact of lymphedema, Lymphedema Life Impact Scale questionnaire LLIS consists of 18 questions divided into physical, functional, and psychosocial domains. The questions are rated from 0-4 with 0 being no symptoms and 4 being severe symptoms., baseline, 3, 6, 9, and 12 months|Disabilities, Disabilities of the Arm, Shoulder and Hand questionnaire The DASH consists of 30 items of disability/symptom scale, each scored from 1 to 5. The final score is converted to a scale of 0 to 100 (higher scores represent higher disability)., baseline, 3, 6, 9, and 12 months|Skin/tissue assessment, Skin/Tissue Assessment: Items assessed include Axillary Web Syndrome (present or absent), presence of visible/palpable lymphedema (location and severity-min/mod/severe), Stemmer's sign (positive or negative)., baseline, 3, 6, 9, and 12 months