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

Completed · Phase 1/Phase 2

Conditions studied: Head and Neck Neoplasms, Head and Neck Lymphedema, Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT02946021

Run by

Tactile Medical

People needed

11

Starts

2016-10-01

Expected to finish

2018-02-01

Last updated by the study team

2019-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UT Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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