Using a home water analyzer to detect early lymphedema in breast cancer patients
Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer
This study is testing whether a home water analyzer can help women with breast cancer spot early signs of lymphedema so they can get treatment sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06580743 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women diagnosed with unilateral breast cancer to assess the efficacy of a home body water analyzer in the early diagnosis and management of lymphedema. The study aims to identify patients who may develop lymphedema, a common complication following breast cancer treatment, by monitoring fluid levels in the body. Participants will be required to have access to a smartphone to facilitate data collection and monitoring. The goal is to enable early intervention, which can lead to better outcomes for patients at risk of developing this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who have been diagnosed with unilateral breast cancer and have undergone specific surgical procedures within the last 12 months.
Not a fit: Patients with bilateral breast cancer or those who already have a diagnosis of lymphedema will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and management of lymphedema, improving quality of life for breast cancer survivors.
How similar studies have performed: While the use of home monitoring devices for lymphedema detection is a relatively novel approach, similar studies have shown promise in early detection of other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Linda A Koehler, PhD — University of Minnesota
- Study coordinator: Linda Koehler
- Email: koeh0139@umn.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.