N/A
N=18
Imaging Biomarkers of Lymphatic Dysfunction
Secondary Lymphedema
Bottom Line
View on ClinicalTrials.gov: NCT03760744 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Assessing a Change in Bioimpedance Spectroscopy (BIS) — 1.3; 1.8 Change of score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CDT with Negative Pressure (Procedure); CDT alone (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessing a Change in Bioimpedance Spectroscopy (BIS) |
1.3; 1.8 | — |
| SECONDARY Assessing a Change in Quality of Life Via Patient Specific Functional Scale (PSFS) |
5.1; 5.0; 6.6; 7.0 | — |
| SECONDARY Tissue Dielectric Constant (TDC) Measurement Difference Above the Elbow |
9.8; 9.4; 8.9; 4.8 | — |
Summary
Persons with secondary arm and/or upper quadrant lymphedema following cancer therapies commonly are prescribed complete decongestive therapy as a course of management of their lymphedema. The investigators will perform a repeated-measures cross-over trial to test the hypothesis that mobilization of protein enriched hardened tissue using graded negative pressure therapy in conjunction with complete decongestive therapy (CDT) is more effective to standard CDT alone for secondary lymphedema management.
Eligibility Criteria
Inclusion Criteria
- Females with a diagnosis of secondary arm and/or upper quadrant lymphedema following cancer treatments
Exclusion Criteria
- Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be able to tolerate the limited fit of the MRI
- Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
- Subjects who may have shrapnel embedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
- Pregnant women will be excluded from the MRI portion of the study only
- Subjects who have open wounds on either ankle or top of foot because of contraindications with placement of electrodes to obtain the L-DEX U400 readings.
- Persons with heart pacemakers.
- Persons with bilateral arm lymphedema (or bilateral risk) or pre-existing lymphedema/edema in the upper body prior to cancer treatments.
Data sourced from ClinicalTrials.gov (NCT03760744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.