Imaging Biomarkers of Lymphatic Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Secondary Lymphedema
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Assessing a Change in Bioimpedance Spectroscopy (BIS)
- Status
- Completed
- Last Updated
- 6 months ago
Overview
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.
Investigators
Manus Donahue
Associate Professor
Vanderbilt University Medical Center
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.
Outcomes
Primary Outcomes
Assessing a Change in Bioimpedance Spectroscopy (BIS)
Time Frame: At baseline and at 6-8 weeks following the completion of therapy
BIS is a noninvasive technology measuring the resistance and reactance of tissue across multiple electrical frequencies using the Impedimed U400 device. By distinguishing ICF from ECF, BIS allows sensitive detection of ECF accumulation, a hallmark of lymphedema. Impedimed's proprietary calculations convert impedance ratios of limbs (involved vs unaffected) into a single output known as LDEX (lymphedema index) with an output normal range of -10 to +10. In situations of overt signs of lymphedema, the LDEX value could be up to 120. This single output value (LDEX) is used in lymphedema research and clinical care to monitor lymphedema progress and response to lymphedema therapy. The LDEX outcome in this study represents the change in LDEX value of the arms from study baseline and at 6-8 weeks following the completion of therapy where a negative value shows a positive response from the therapy intervention by indicating a reduction in the LDEX value.
Secondary Outcomes
- Assessing a Change in Quality of Life Via Patient Specific Functional Scale (PSFS)(At baseline (pre-intervention) and at 6-8 weeks following the completion of each therapy (post-intervention))
- Tissue Dielectric Constant (TDC) Measurement Difference Above the Elbow(At baseline (pre-intervention) and at 6-8 weeks following the completion of each therapy ([post intervention ))