An observational study in Breast Cancer, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by University of Minnesota · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 52 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
check inclusion criteria
Exclusion Criteria:
breast cancer patients 1-12 months post surgery
Other: No intervention
This is an observational study
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
Time frame: 3, 6, 9, and 12 months
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.
Time frame: 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.
Time frame: 12 months
Bilateral upper extremity shoulder goniometric range of motion measurements
measured in degrees
Time frame: baseline, 3, 6, 9, and 12 months
Bilateral upper extremity girth circumference measurements
measured in centimeters
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: baseline, 3, 6, 9, and 12 months
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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