Secondary Lymphedema Clinical Trial
Official title:
Imaging Biomarkers of Lymphatic Dysfunction
Verified date | June 2024 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 18 |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Institute of Nursing Research (NINR), National Institutes of Health (NIH) |
United States,
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
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 |
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