Imaging Biomarkers of Lymphatic Dysfunction

Secondary Lymphedema Clinical Trial

Official title:

Imaging Biomarkers of Lymphatic Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03760744
• Other study ID #: 131172
• Secondary ID: 1R01NR015079
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: Paula M Donahue, DPT
• Phone: 615-343-0389
• Email: paula.m.donahue[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema
• Secondary Lymphedema

Intervention

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
• CDT alone
Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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