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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer Related Lymphedema
• Intervention / Treatment: Device: Flexitouch Plus; Device: Flexitouch Plus FT with software modification

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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
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.

Collaborators and Investigators

• Sponsor: Tactile Medical

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): February 8, 2020
• Study Completion (Actual): February 8, 2020

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema; Unilateral Breast Neoplasms
• Other Study ID Numbers: 4070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No