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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR015079 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDT Alone first, then CDT With Negative Pressure | Experimental | Participants randomized into a CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration). This is followed by a 6 month washout period, then a second intervention consisting of CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) |
|
| CDT With Negative Pressure first, then CDT Alone | Active Comparator | Participants randomized into a CDT with LymphaTouch Negative Pressure for 6 weeks, total of 9 therapy visits (75minutes duration). This is followed by a 6 month washout period, then a second intervention consisting of CDT alone without Negative Pressure for 6 weeks, total of 9 therapy visits (75minutes duration) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDT with Negative Pressure | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing a Change in Bioimpedance Spectroscopy (BIS) | 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. | At baseline and at 6-8 weeks following the completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing a Change in Quality of Life Via Patient Specific Functional Scale (PSFS) | The Patient Specific Functional Scale (PSFS) was developed as a self-report outcome measure of function that could be used in participants with varying levels of independence. Each participant chose a set of three daily activities and rated the level of ease and comfort with which they could complete them pre and post each intervention. Rating scale starts at 0 (unable to perform activity) and goes to goes up to 10 (able to perform activity at the same level as before injury or problem). The closer to 10, the more favorable the number is. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manus M Donahue, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28323572 | Background | 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. | |
| 28245075 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CDT Alone First, Then CDT With Negative Pressure | A total of 9 therapy visits (75minutes duration) of CDT alone without LymphaTouch was administered for 6 weeks. After a six month washout participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT with Negative Pressure. CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance. conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) 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. |
| FG001 | CDT With Negative Pressure First, Then CDT Alone | A total of 9 therapy visits (75minutes duration) of CDT alone with LymphaTouch negative pressure was administered for 6 weeks. After a six month washout participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT without Negative Pressure. CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance. conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants analyzed were females with unilateral breast-cancer related lymphedema of the upper arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | CDT Alone First, Then CDT With Negative Pressure | A total of 9 therapy visits (75minutes duration) of CDT alone without LymphaTouch was administered for 6 weeks. After a six month washout period, participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT with Negative Pressure. CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessing a Change in Bioimpedance Spectroscopy (BIS) | 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. | Posted | Mean | Standard Deviation | Change of score on a scale | At baseline and at 6-8 weeks following the completion of therapy | affected vs unaffected limbs | affected vs unaffected limbs |
|
2 years, 4 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDT Alone | CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manus J. Donahue | Vanderbilt Medical Center | 615.322.8350 | mj.donahue@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2025 | Jul 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C056759 | carbohydrate-deficient transferrin |
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|
|
| CDT alone | Procedure | Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance |
|
|
| 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 | TDC measures the skin-to-fat water content in tissues. The location was chosen given the propensity of swelling and discomfort in the area for participant population. This measurement compares the TDC value in the affected limb versus the unaffected limb, therefore the closer the TDC measurement difference is to zero, the more favorable the value is. | At baseline (pre-intervention) and at 6-8 weeks following the completion of each therapy ([post intervention ) |
| 37684712 | Derived | Donahue MJ, Donahue PMC, Jones RS, Garza M, Lee C, Patel NJ, Cooper A, De Vis JB, Meszoely I, Crescenzi R. In vivo lymph node CEST-Dixon MRI in breast cancer patients with metastatic lymph node involvement. Magn Reson Med. 2024 Feb;91(2):670-680. doi: 10.1002/mrm.29858. Epub 2023 Sep 8. |
| BG001 | CDT With Negative Pressure First, Then CDT Alone | A total of 9 therapy visits (75minutes duration) of CDT with LymphaTouch Negative Pressure was administered for 6 weeks. After a six month washout period, participants were brought back in for another 9 therapy visits (75minutes duration) administered over 6 weeks of CDT Alone, without Negative Pressure. CDT Alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | CDT Alone | CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) CDT alone: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance |
| OG001 | CDT With Negative Pressure | CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) 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 |
|
|
| Secondary | Assessing a Change in Quality of Life Via Patient Specific Functional Scale (PSFS) | The Patient Specific Functional Scale (PSFS) was developed as a self-report outcome measure of function that could be used in participants with varying levels of independence. Each participant chose a set of three daily activities and rated the level of ease and comfort with which they could complete them pre and post each intervention. Rating scale starts at 0 (unable to perform activity) and goes to goes up to 10 (able to perform activity at the same level as before injury or problem). The closer to 10, the more favorable the number is. | Posted | Mean | Standard Deviation | PSFS score | At baseline (pre-intervention) and at 6-8 weeks following the completion of each therapy (post-intervention) |
|
|
|
| Secondary | Tissue Dielectric Constant (TDC) Measurement Difference Above the Elbow | TDC measures the skin-to-fat water content in tissues. The location was chosen given the propensity of swelling and discomfort in the area for participant population. This measurement compares the TDC value in the affected limb versus the unaffected limb, therefore the closer the TDC measurement difference is to zero, the more favorable the value is. | While participants started in different groups, all 15 analyzed participants went through both arms of the study after a washout period. This number represents all participants who completed both arms of the study. | Posted | Mean | Standard Deviation | TDC % change | At baseline (pre-intervention) and at 6-8 weeks following the completion of each therapy ([post intervention ) | affected limb versus the unaffected limb | affected limb versus the unaffected limb |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | CDT With Negative Pressure | CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration) 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 | 0 | 15 | 0 | 15 | 0 | 15 |
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