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

NCT06580743 | Completed

• 1 other identifier: PT-2024-32330
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Measurement of impedances and extracellular water (ECW) ratio

  3, 6, 9, and 12 months

• attitudes

  12 months

• Bilateral upper extremity shoulder goniometric range of motion measurements

  baseline, 3, 6, 9, and 12 months

• Bilateral upper extremity girth circumference measurements

  baseline, 3, 6, 9, and 12 months

• Impact of lymphedema

  baseline, 3, 6, 9, and 12 months

Study Arms (1)

Study group

breast cancer patients 1-12 months post surgery

Other: No intervention

Interventions

No intervention OTHER

This is an observational study

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

check inclusion criteria

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Linda A Koehler, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 30, 2024
• Study Start: June 12, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)