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Imaging Biomarkers of Lymphatic Dysfunction

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ClinicalTrials.gov Identifier: NCT03760744
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Manus Donahue, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Secondary Lymphedema Procedure: CDT with Negative Pressure Procedure: CDT alone Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Imaging Biomarkers of Lymphatic Dysfunction
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: CDT with Negative Pressure
CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
Procedure: CDT with Negative Pressure
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
Other Name: CDT with LymphaTouch

Active Comparator: CDT alone
CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
Procedure: CDT alone
Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance
Other Name: Complete decongestive therapy without negative pressure




Primary Outcome Measures :
  1. Assessing a Change in Bioimpedance Spectroscopy (BIS) [ Time Frame: At baseline and at 6-8 weeks following the completion of each therapy ]
    BIS quantified using Impedimed L-dex at baseline and following course of each treatment (cross over design)


Secondary Outcome Measures :
  1. Assessing a Change in Lymphatic Stasis [ Time Frame: At baseline and at 6-8 weeks following the completion of each therapy ]
    Quantitative analysis of lymphatic stasis using non-invasive MR lymphangiography at baseline and following course of each treatment (cross over design)

  2. Assessing a Change in Limb Volume [ Time Frame: At baseline and at 6-8 weeks following the completion of each therapy ]
    Volume quantified using Perometer at baseline and following course of each treatment (cross over design)



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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760744


Contacts
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Contact: Paula M Donahue, DPT 615-343-0389 paula.m.donahue@vumc.org
Contact: Chelsea A Lee, BS chelsea.a.lee@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Manus M Donahue, PhD Vanderbilt University Medical Center

Publications:
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Responsible Party: Manus Donahue, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03760744     History of Changes
Other Study ID Numbers: 131172
1R01NR015079 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manus Donahue, Vanderbilt University Medical Center:
lymphedema
therapy
swelling
graded negative pressure
complete decongestive therapy

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases