Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Jun 29, 2023

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Participants must be 18 years of age or older
• • Participants must have previously been diagnosed with head and neck cancer and undergone surgery and radiation as part of their standard-of-care treatment plan
• • Participants must be ≥ 4 weeks but less than 3 months post-radiation therapy at enrollment
• • 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
• • Male participants must agree to shave facial hair on imaging days
• • Participants must be willing and able to independently use the pneumatic compression device at home daily for up to 12 months as directed by study personnel.
• Exclusion Criteria:
• • Persons who are pregnant or breast-feeding
• • Females of child-bearing potential, who do not agree to use an approved contraceptive for one month after each imaging session
• • Persons who do not meet inclusion criteria
• • Iodine allergy
• • Persons with a chest circumference of 150 cm or more
• • Uncontrolled hyperthyroidism or parathyroidism (for which 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 or internal jugular venous thrombosis (within 3 months)
• • Increased 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 to 8-weeks post-operative
• • Facial or head and neck dermal metastasis
• • Acute facial infection (e.g., facial, or parotid gland abscess)
• • Heart failure (acute pulmonary edema, decompensated acute heart failure)
• • Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
• • Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
• • Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin, or untreated inflammatory skin disease)
• • Any condition where increased venous and lymphatic return is undesirable