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

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Assessment of lymphatic structure and function pre- and post- treatment and during recovery in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging: Response to ICD therapy in HNC Patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tactile Medical

Criteria

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