Imaging Biomarkers of Lymphatic Dysfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Imaging Biomarkers of Lymphatic Dysfunction

Conditions
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Secondary Lymphedema

Intervention / Treatment
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* Procedure: CDT with Negative Pressure
* Procedure: CDT alone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDT with Negative Pressure<br>CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) | Procedure: CDT with Negative Pressure<br>* Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance<br>* Other names: CDT with LymphaTouch;|
| Active Comparator: CDT alone<br>CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) | Procedure: CDT alone<br>* Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance<br>* Other names: Complete decongestive therapy without negative pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing a Change in Bioimpedance Spectroscopy (BIS) | BIS quantified using Impedimed L-dex at baseline and following course of each treatment (cross over design) | At baseline and at 6-8 weeks following the completion of each therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing a Change in Lymphatic Stasis | Quantitative analysis of lymphatic stasis using non-invasive MR lymphangiography at baseline and following course of each treatment (cross over design) | At baseline and at 6-8 weeks following the completion of each therapy | 
| Assessing a Change in Limb Volume | Volume quantified using Perometer at baseline and following course of each treatment (cross over design) | At baseline and at 6-8 weeks following the completion of each therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, therapy, swelling, graded negative pressure, complete decongestive therapy