Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-related Lymphedema

A non-randomized, non-blinded, single site pilot study designed to assess whether
near-infrared fluorescence imaging can report on the efficacy of a pneumatic compression
device to move lymph in head and neck cancer survivors with resulting head and neck
lymphedema.

Inclusion Criteria:

- Participants must be 18 years of age or older

- Participants must be diagnosed with Lymphedema of the Head and/or Neck

- Participants must be diagnosed with squamous cell carcinoma of the oral cavity,
oropharynx or larynx and underwent surgery and radiation as part of their
standard-of-care treatment plan.

- Participants must be ≥ 4 weeks post-radiation therapy

- Female participants of childbearing potential must have a negative urine pregnancy
test ≤ 36 hours prior to study drug administration

- Female participants of childbearing potential must agree to use a medically accepted
method of contraception for a period of one month after each imaging session

- Participants must be willing to use the Flexitouch® System at home daily for two (2)
weeks

Exclusion Criteria:

- Women who are pregnant or breast-feeding

- Persons who are allergic to iodine

- A female of child-bearing potential, who does not agree to use an approved
contraceptive for one month after study participation

- Persons who do not meet inclusion criteria

- Persons with pulmonary edema, thrombophlebitis, congestive heart failure, deep vein
thrombosis, episodes of pulmonary embolism, infections and inflammation, or acute
cancer

- Persons with uncontrolled hyperthyroidism or parathyroidism (for with an
endocrinologist recommends against neck compression)

- Carotid sinus hypersensitivity syndrome

- Symptomatic carotid artery disease, as manifested by a recent transient ischemic
attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual
ischemic symptoms or blindness)

- Symptomatic bradycardia in the absence of a pacemaker

- Internal jugular venous thrombosis, acute or within 3 months

- Known intracranial pressure or other contraindication to internal or external jugular
venous compression

- Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s),
surgical flap less than 6-8 weeks post-operative

- Facial or head and neck dermal metastasis

- Acute facial infection (e.g., facial or parotid gland abscess)

- Any condition where increased venous and lymphatic return is undesirable