A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients

Study Overview
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Brief Summary
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The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.

Official Title
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A Feasibility Study Evaluating Flexitouch® Plus With a Therapy Cycle Software Modification in Patients With Unilateral Breast Cancer-Related Lymphedema (BCRL)

Conditions
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Breast Cancer Related Lymphedema

Intervention / Treatment
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* Device: Flexitouch Plus
* Device: Flexitouch Plus FT with software modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 years of age or older Diagnosis of unilateral breast cancer-related lymphedema Stage I or early stage II lymphedema without severe fibrosis at the time of enrollment ≥ 5% volume difference between affected and unaffected arm as verified via perometry Willing and able to give informed consent Willing and able to comply with the study protocol requirements and all study-related visit requirements Exclusion Criteria: In-home use of PCD within previous 3 months Therapist or self-administered manual lymph drainage (MLD) within previous 1 week Mastectomy or lymph node removal on side without lymphedema Bilateral lymphedema Heart failure (acute pulmonary edema, decompensated acute heart failure) Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk Active cancer (cancer that is currently under treatment, but not yet in remission) Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome BMI >50 Any circumstance where increased lymphatic or venous return is undesirable Currently pregnant or trying to become pregnant Allergy to iodine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flexitouch Plus<br> | Device: Flexitouch Plus<br>* Flexitouch Plus full arm and core treatment<br>|
| Experimental: Flexitouch Plus with SW<br> | Device: Flexitouch Plus FT with software modification<br>* Flexitouch Plus full arm and trunk/chest treatment<br>* Other names: FT-SW;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphatic Activation | Comparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging. | Baseline and following a single treatment, an average of one hour | 
| Changes in Swelling - MoistureMeterD | Comparison of the percent change in local tissue water from the pre-treatment values to the post-treatment values on the affected limb using MoistureMeterD. | Baseline and following a single treatment, an average of one hour | 
| Changes in Swelling - Perometry | Swelling in the affected and contralateral limb as assessed using local tissue water content | Baseline and following a single treatment, an average of one hour | 
| Percent Change in Skin Thickness From Baseline to After Treatment. | Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound). | Baseline and following a single treatment, an average of one hour | 
| Incidence of Adverse Events | Adverse events reported between treatment and the 24-hour follow-up | 24-Hour Follow-Up | 
| Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging | Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging. | Baseline and following a single treatment, an average of one hour | 
| Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Comparison of the change in dermal backflow from the pre-treatment values to the post-treatment values as the sum of the volume of area for all locations for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging | Baseline and following a single treatment, an average of one hour | 
| Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner) | Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner) | Baseline and following a single treatment, an average of one hour | 
| Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Comparison of the percent of participants by arm demonstrating a decrease in thickness for each site, separating skin and subcutaneous changes, on the affected limb via Ultrasound | Baseline and following a single treatment, an average of one hour | 
| Absolute Change in Skin Thickness From Baseline to After Treatment | Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound). | Baseline and following a single treatment, an average of one hour. |