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.

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