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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

check inclusion criteria

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; breast cancer patients 1-12 months post surgery	Other: No intervention; This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Linda A Koehler, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: PT-2024-32330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No