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Imaging Biomarkers of Lymphatic Dysfunction

Primary Purpose

Secondary Lymphedema

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CDT with Negative Pressure
CDT alone
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Lymphedema focused on measuring lymphedema, therapy, swelling, graded negative pressure, complete decongestive therapy

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CDT with Negative Pressure

CDT alone

Arm Description

CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)

CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)

Outcomes

Primary Outcome Measures

Assessing a Change in Bioimpedance Spectroscopy (BIS)
BIS quantified using Impedimed L-dex at baseline and following course of each treatment (cross over design)

Secondary Outcome Measures

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)
Assessing a Change in Limb Volume
Volume quantified using Perometer at baseline and following course of each treatment (cross over design)

Full Information

First Posted
November 28, 2018
Last Updated
May 2, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03760744
Brief Title
Imaging Biomarkers of Lymphatic Dysfunction
Official Title
Imaging Biomarkers of Lymphatic Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Lymphedema
Keywords
lymphedema, therapy, swelling, graded negative pressure, complete decongestive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CDT with Negative Pressure
Arm Type
Experimental
Arm Description
CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
Arm Title
CDT alone
Arm Type
Active Comparator
Arm Description
CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
Intervention Type
Procedure
Intervention Name(s)
CDT with Negative Pressure
Other Intervention Name(s)
CDT with LymphaTouch
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
CDT alone
Other Intervention Name(s)
Complete decongestive therapy without negative pressure
Intervention Description
Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance
Primary Outcome Measure Information:
Title
Assessing a Change in Bioimpedance Spectroscopy (BIS)
Description
BIS quantified using Impedimed L-dex at baseline and following course of each treatment (cross over design)
Time Frame
At baseline and at 6-8 weeks following the completion of each therapy
Secondary Outcome Measure Information:
Title
Assessing a Change in Lymphatic Stasis
Description
Quantitative analysis of lymphatic stasis using non-invasive MR lymphangiography at baseline and following course of each treatment (cross over design)
Time Frame
At baseline and at 6-8 weeks following the completion of each therapy
Title
Assessing a Change in Limb Volume
Description
Volume quantified using Perometer at baseline and following course of each treatment (cross over design)
Time Frame
At baseline and at 6-8 weeks following the completion of each therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula M Donahue, DPT
Phone
615-343-0389
Email
paula.m.donahue@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maria E Garza, BS
Email
maria.e.garza@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manus M Donahue, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28323572
Citation
Donahue PM, Crescenzi R, Scott AO, Braxton V, Desai A, Smith SA, Jordi J, Meszoely IM, Grau AM, Kauffmann RM, Sweeting RS, Spotanski K, Ridner SH, Donahue MJ. Bilateral Changes in Deep Tissue Environment After Manual Lymphatic Drainage in Patients with Breast Cancer Treatment-Related Lymphedema. Lymphat Res Biol. 2017 Mar;15(1):45-56. doi: 10.1089/lrb.2016.0020.
Results Reference
background
PubMed Identifier
28245075
Citation
Crescenzi R, Donahue PMC, Hartley KG, Desai AA, Scott AO, Braxton V, Mahany H, Lants SK, Donahue MJ. Lymphedema evaluation using noninvasive 3T MR lymphangiography. J Magn Reson Imaging. 2017 Nov;46(5):1349-1360. doi: 10.1002/jmri.25670. Epub 2017 Feb 28.
Results Reference
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Imaging Biomarkers of Lymphatic Dysfunction

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