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Trial Title:
Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer
NCT ID:
NCT06580743
Condition:
Breast Cancer
Conditions: Official terms:
Lymphedema
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
This is an observational study
Arm group label:
Study group
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.
Criteria for eligibility:
Study pop:
check inclusion criteria
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55414
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eric Fredrickson
Start date:
June 12, 2024
Completion date:
October 1, 2025
Lead sponsor:
Agency:
University of Minnesota
Agency class:
Other
Source:
University of Minnesota
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06580743
