Back to resultsA Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
Primary Purpose
Breast Cancer Related Lymphedema
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexitouch Plus
Flexitouch Plus FT with software modification
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Related Lymphedema
Eligibility Criteria
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
Sites / Locations
- University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Flexitouch Plus
Flexitouch Plus with SW
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Changes in Swelling - Perometry
Swelling in the affected and contralateral limb as assessed using local tissue water content
Percent Change in Skin Thickness From Baseline to After Treatment.
Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Incidence of Adverse Events
Adverse events reported between treatment and the 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.
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
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)
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
Absolute Change in Skin Thickness From Baseline to After Treatment
Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04073823
Brief Title
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
Official Title
A Feasibility Study Evaluating Flexitouch® Plus With a Therapy Cycle Software Modification in Patients With Unilateral Breast Cancer-Related Lymphedema (BCRL)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to unforeseen slow enrollment and a shift in corporate resources due to the COVID-19 impact.
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
February 8, 2020 (Actual)
Study Completion Date
February 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tactile Medical
4. Oversight
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
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Related Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexitouch Plus
Arm Type
Active Comparator
Arm Title
Flexitouch Plus with SW
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Flexitouch Plus
Intervention Description
Flexitouch Plus full arm and core treatment
Intervention Type
Device
Intervention Name(s)
Flexitouch Plus FT with software modification
Other Intervention Name(s)
FT-SW
Intervention Description
Flexitouch Plus full arm and trunk/chest treatment
Primary Outcome Measure Information:
Title
Lymphatic Activation
Description
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.
Time Frame
Baseline and following a single treatment, an average of one hour
Title
Changes in Swelling - MoistureMeterD
Description
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.
Time Frame
Baseline and following a single treatment, an average of one hour
Title
Changes in Swelling - Perometry
Description
Swelling in the affected and contralateral limb as assessed using local tissue water content
Time Frame
Baseline and following a single treatment, an average of one hour
Title
Percent Change in Skin Thickness From Baseline to After Treatment.
Description
Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Time Frame
Baseline and following a single treatment, an average of one hour
Title
Incidence of Adverse Events
Description
Adverse events reported between treatment and the 24-hour follow-up
Time Frame
24-Hour Follow-Up
Title
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Description
Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
Time Frame
Baseline and following a single treatment, an average of one hour
Title
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Description
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
Time Frame
Baseline and following a single treatment, an average of one hour
Title
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
Description
Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
Time Frame
Baseline and following a single treatment, an average of one hour
Title
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Description
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
Time Frame
Baseline and following a single treatment, an average of one hour
Title
Absolute Change in Skin Thickness From Baseline to After Treatment
Description
Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Time Frame
Baseline and following a single treatment, an average of one hour.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
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