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OpenTrials
Completed

NCT Number: NCT06580743

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is an observational study

Primary outcomes

  1. Measurement of impedances and extracellular water (ECW) ratio

    Time frame: 3, 6, 9, and 12 months

    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

Secondary outcomes

  1. Measurement of impedances and extracellular water (ECW) ratio

    Time frame: 3, 6, 9, and 12 months

    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.

  2. attitudes

    Time frame: 12 months

    Measure qualitative responses through exit interviews with participants to learn their attitudes toward their evaluation with the home BIA home device at 12 months.

  3. Bilateral upper extremity shoulder goniometric range of motion measurements

    Time frame: baseline, 3, 6, 9, and 12 months

    measured in degrees

  4. Bilateral upper extremity girth circumference measurements

    Time frame: baseline, 3, 6, 9, and 12 months

    measured in centimeters

  5. Impact of lymphedema

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

  6. Disabilities

    Time frame: baseline, 3, 6, 9, and 12 months

    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).

  7. Skin/tissue assessment

    Time frame: baseline, 3, 6, 9, and 12 months

    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).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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