Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Lymphedema of Face, Head and Neck Cancer
About this trial
This is an interventional treatment trial for Lymphedema of Face focused on measuring indocyanine green imaging, head and neck cancer-acquired lymphedema, near-infrared fluorescence lymphatic imaging, advanced pneumatic compression therapy
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Other
Advanced Pneumatic Compression
Standard-of-Care
No Dermal Backflow
Subjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home.
Subjects who present with dermal lymphatic backflow will continue under standard-of-care surveillance of lymphedema and will only receive treatment if they are diagnosed with head and neck cancer-acquired lymphedema.
Subjects who do not present with dermal lymphatic backflow at enrollment will be monitored at subsequent visits and if/when dermal lymphatic backflow is observed will be randomized into either Advanced Pneumatic Compression or Standard-of-Care arm.