Imaging Biomarkers of Lymphatic Dysfunction



Status:Recruiting
Healthy:No
Age Range:30 - 90
Updated:2/28/2019
Start Date:January 23, 2019
End Date:June 1, 2022
Contact:Paula M Donahue, DPT
Email:paula.m.donahue@vumc.org
Phone:615-343-0389

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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.

The goal of this work is to apply novel, noninvasive magnetic resonance imaging (MRI) methods
for visualizing lymphatic circulation dysfunction to test a fundamental hypothesis about
secondary lymphedema conservative decongestive therapy. Breast cancer treatment-related
lymphedema (BCRL) arises secondary to surgical axillary lymph node (LN) dissection and
irritation, and is a chronic and lifelong condition affecting a high 21.4% of patients
receiving common breast cancer therapies. Persons with secondary lymphedema following
axillary lymph node removal also include undergoing treatment for other cancers, such as
melanoma involving the upper body, necessitating the need for axially lymph node removal.

Improving lymphedema management represents a major clinical need, and emerging efforts focus
on improving quality of life through optimizing post-surgical complex decongestive therapy
(CDT), and exploring novel pharmacological and surgical procedures. Here, 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. Both of these conservative physical therapy treatments are commonly
employed for treatment of secondary lymphedema.

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.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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mi
from
Nashville, TN
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