Clinical trial NCT06580743: Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer
Official title: Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: check inclusion criteria

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of impedances and extracellular water (ECW) ratio
timeFrame: 3, 6, 9, and 12 months
Secondary outcomes:
measure: Measurement of impedances and extracellular water (ECW) ratio
timeFrame: 3, 6, 9, and 12 months
measure: attitudes
timeFrame: 12 months
measure: Bilateral upper extremity shoulder goniometric range of motion measurements
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Bilateral upper extremity girth circumference measurements
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Impact of lymphedema
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Disabilities
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Skin/tissue assessment
timeFrame: baseline, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Linda A Koehler, PhD
role: PRINCIPAL_INVESTIGATOR
References: