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

Phase 1

Completed

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

Interventions: Device: Head and neck garments for pneumatic compression device
Drug: NIRFLI with ICG

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pneumatic Compression-1 session per day	Head and neck garments for pneumatic compression device	Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Pneumatic Compression-1 session per day	NIRFLI with ICG	Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Pneumatic Compression-2 sessions per day	Head and neck garments for pneumatic compression device	Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Pneumatic Compression-2 sessions per day	NIRFLI with ICG	Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).

Primary Outcome Measures

Name	Time	Method
Lymph Movement Measured by ICG Lymphography.	Single Treatment, 2 Weeks of Treatment	Demonstrate the ability of the Flexitouch system to move lymph/enhance lymphatic uptake (indicated by increased functionality of vessels and/or changes in area of dermal backflow) as measured by Indocyanine Green (ICG) lymphography.

Secondary Outcome Measures

Name	Time	Method
Dermal Backflow Measured by ICG Lymphography.	Single Treatment, 2 Weeks of Treatment	Resolves dermal backflow as measured by ICG lymphography. A positive change in area indicates an increase in observable abnormal lymphatics, while a negative change indicates a decrease in observable abnormal lymphatics. A positive increase after a single treatment is expected as the manual stimulation of the lymphatics promotes the movement of ICG through the lymphatic space; however, a decrease over time provides an indication of improved lymphatic recovery.
Symptom Alleviation Measured by Survey Response.	Single Treatment, 2 Weeks of Treatment	Alleviates lymphedema symptoms as measured by survey response.
Ease of Use Measured by Survey Response.	Single Treatment, 2 Weeks of Treatment	Flexitouch is easy to use as measured by survey responses.