Clinical trial NCT04073823: 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
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Lymphatic Activation
timeFrame: Baseline and following a single treatment, an average of one hour
measure: Changes in Swelling - MoistureMeterD
timeFrame: Baseline and following a single treatment, an average of one hour
measure: Changes in Swelling - Perometry
timeFrame: Baseline and following a single treatment, an average of one hour
measure: Percent Change in Skin Thickness From Baseline to After Treatment.
timeFrame: Baseline and following a single treatment, an average of one hour
measure: Incidence of Adverse Events
timeFrame: 24-Hour Follow-Up
measure: Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
timeFrame: Baseline and following a single treatment, an average of one hour
measure: Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
timeFrame: Baseline and following a single treatment, an average of one hour
measure: Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
timeFrame: Baseline and following a single treatment, an average of one hour
measure: Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
timeFrame: Baseline and following a single treatment, an average of one hour
measure: Absolute Change in Skin Thickness From Baseline to After Treatment
timeFrame: Baseline and following a single treatment, an average of one hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
References: