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

Breast Cancer Related Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04073823
• Other study ID #: 4070
• Status: Terminated
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: February 8, 2020

Study information

• Verified date: January 2023
• Source: Tactile Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 8, 2020
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• Flexitouch Plus
Flexitouch Plus full arm and core treatment
• Flexitouch Plus FT with software modification
Flexitouch Plus full arm and trunk/chest treatment

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Incidence of Adverse Events	Adverse events reported between treatment and the 24-hour follow-up	24-Hour Follow-Up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.