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Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer

NCT06580743 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No intervention

This is an observational study

Sponsors & Collaborators

Principal Investigators

  • Linda A Koehler, PhD · University of Minnesota

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
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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 NCT06580743 on ClinicalTrials.gov