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.
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
