A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients

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