Breast Cancer Related Lymphedema
Conditions
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.
Interventions
DEVICEFlexitouch Plus
Flexitouch Plus full arm and core treatment
DEVICEFlexitouch Plus FT with software modification
Flexitouch Plus full arm and trunk/chest treatment
Sponsors
Tactile Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Skin Thickness From Baseline to After Treatment. | 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). |
| Incidence of Adverse Events | 24-Hour Follow-Up | Adverse events reported between treatment and the 24-hour follow-up |
| Lymphatic Activation | Baseline and following a single treatment, an average of one hour | 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 | Baseline and following a single treatment, an average of one hour | 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 | Baseline and following a single treatment, an average of one hour | Swelling in the affected and contralateral limb as assessed using local tissue water content |
| Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging | Baseline and following a single treatment, an average of one hour | 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 | Baseline and following a single treatment, an average of one hour | 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) | Baseline and following a single treatment, an average of one hour | 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) | Baseline and following a single treatment, an average of one hour | 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flexitouch Plus Flexitouch Plus: Flexitouch Plus full arm and core treatment | 1 |
| Flexitouch Plus With SW Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Flexitouch Plus With SW | Total | Flexitouch Plus |
|---|---|---|---|
| Age, Continuous | 81 years | 67 years | 53 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
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).
Time frame: Baseline and following a single treatment, an average of one hour.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Flexitouch Plus | Absolute Change in Skin Thickness From Baseline to After Treatment | Affected Limb Absolute Change | -1.70 mm |
| Flexitouch Plus | Absolute Change in Skin Thickness From Baseline to After Treatment | Contralateral Limb Absolute Change | -0.52 mm |
| Flexitouch Plus With SW | Absolute Change in Skin Thickness From Baseline to After Treatment | Affected Limb Absolute Change | -0.03 mm |
| Flexitouch Plus With SW | Absolute Change in Skin Thickness From Baseline to After Treatment | Contralateral Limb Absolute Change | -1.54 mm |
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.
Time frame: Baseline and following a single treatment, an average of one hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Flexitouch Plus | Changes in Swelling - MoistureMeterD | -4.0 Percent Change |
| Flexitouch Plus With SW | Changes in Swelling - MoistureMeterD | -6.4 Percent Change |
Primary
Changes in Swelling - Perometry
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flexitouch Plus | Changes in Swelling - Perometry | Affected Limb | 1.6 Percent Change |
| Flexitouch Plus | Changes in Swelling - Perometry | Contralateral Limb | 0.5 Percent Change |
| Flexitouch Plus With SW | Changes in Swelling - Perometry | Affected Limb | -1.6 Percent Change |
| Flexitouch Plus With SW | Changes in Swelling - Perometry | Contralateral Limb | 0.7 Percent Change |
Primary
Incidence of Adverse Events
Adverse events reported between treatment and the 24-hour follow-up
Time frame: 24-Hour Follow-Up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flexitouch Plus | Incidence of Adverse Events | 0 Participants |
| Flexitouch Plus With SW | Incidence of Adverse Events | 0 Participants |
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.
Time frame: Baseline and following a single treatment, an average of one hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flexitouch Plus | Lymphatic Activation | Affected Limb | 0.0 Percent Rate Change |
| Flexitouch Plus | Lymphatic Activation | Contralateral Limb | -3.0 Percent Rate Change |
| Flexitouch Plus With SW | Lymphatic Activation | Affected Limb | -50 Percent Rate Change |
| Flexitouch Plus With SW | Lymphatic Activation | Contralateral Limb | 241.2 Percent Rate Change |
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).
Time frame: Baseline and following a single treatment, an average of one hour
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Flexitouch Plus | Percent Change in Skin Thickness From Baseline to After Treatment. | Affected Limb Percent Change | 116.1 Percent Change |
| Flexitouch Plus | Percent Change in Skin Thickness From Baseline to After Treatment. | Contralateral Limb Percent Change | 15.2 Percent Change |
| Flexitouch Plus With SW | Percent Change in Skin Thickness From Baseline to After Treatment. | Affected Limb Percent Change | 5.6 Percent Change |
| Flexitouch Plus With SW | Percent Change in Skin Thickness From Baseline to After Treatment. | Contralateral Limb Percent Change | 184.2 Percent Change |
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.
Time frame: Baseline and following a single treatment, an average of one hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flexitouch Plus | Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging | Affected Limb | 0 Participants |
| Flexitouch Plus | Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging | Contralateral Limb | 1 Participants |
| Flexitouch Plus With SW | Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging | Affected Limb | 0 Participants |
| Flexitouch Plus With SW | Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging | Contralateral Limb | 1 Participants |
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
Time frame: Baseline and following a single treatment, an average of one hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flexitouch Plus | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Affected Limb (Lateral Lower) | 65.4 Percent Change |
| Flexitouch Plus | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Contralateral Limb (Lateral Lower) | 0.0 Percent Change |
| Flexitouch Plus | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Affected Limb (Medial Lower) | 19.0 Percent Change |
| Flexitouch Plus | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Contralateral Limb (Medial Lower) | 0.0 Percent Change |
| Flexitouch Plus | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Affected Limb (Medial Upper) | 47.8 Percent Change |
| Flexitouch Plus | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Contralateral Limb (Medial Upper) | 0.0 Percent Change |
| Flexitouch Plus With SW | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Affected Limb (Medial Upper) | 0.0 Percent Change |
| Flexitouch Plus With SW | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Affected Limb (Lateral Lower) | 20.6 Percent Change |
| Flexitouch Plus With SW | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Contralateral Limb (Medial Lower) | 0.0 Percent Change |
| Flexitouch Plus With SW | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Contralateral Limb (Lateral Lower) | 0.0 Percent Change |
| Flexitouch Plus With SW | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Contralateral Limb (Medial Upper) | 0.0 Percent Change |
| Flexitouch Plus With SW | Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging | Affected Limb (Medial Lower) | -19.8 Percent Change |
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
Time frame: Baseline and following a single treatment, an average of one hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flexitouch Plus | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Skin Thickness (Site A) | 100 Percent of Participants |
| Flexitouch Plus | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Skin Thickness (Site B) | 0 Percent of Participants |
| Flexitouch Plus | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Skin Thickness (Site C) | 0 Percent of Participants |
| Flexitouch Plus | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Subcutaneous Thickness (Site A) | 0 Percent of Participants |
| Flexitouch Plus | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Subcutaneous Thickness (Site B) | 0 Percent of Participants |
| Flexitouch Plus | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Subcutaneous Thickness (Site C) | 100 Percent of Participants |
| Flexitouch Plus With SW | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Subcutaneous Thickness (Site B) | 0 Percent of Participants |
| Flexitouch Plus With SW | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Skin Thickness (Site A) | 100 Percent of Participants |
| Flexitouch Plus With SW | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Subcutaneous Thickness (Site A) | 100 Percent of Participants |
| Flexitouch Plus With SW | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Skin Thickness (Site B) | 100 Percent of Participants |
| Flexitouch Plus With SW | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Subcutaneous Thickness (Site C) | 0 Percent of Participants |
| Flexitouch Plus With SW | Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound) | Skin Thickness (Site C) | 100 Percent of Participants |
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)
Time frame: Baseline and following a single treatment, an average of one hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flexitouch Plus | Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner) | Affected Limb | 0 Percentage of Participants |
| Flexitouch Plus | Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner) | Contralateral Limb | 0 Percentage of Participants |
| Flexitouch Plus With SW | Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner) | Affected Limb | 100 Percentage of Participants |
| Flexitouch Plus With SW | Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner) | Contralateral Limb | 0 Percentage of Participants |