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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Lymphatic Structure and Function Pre- and Post- Treatment and During Recovery in Head and Neck Cancer Patients Using NIR Fluorescence Lymphatic Imaging

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

Intervention / Treatment
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* Device: Head and neck garments for pneumatic compression device
* Drug: NIRFLI with ICG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumatic Compression-1 session per day<br>Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green). | Device: Head and neck garments for pneumatic compression device<br>* Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds; and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema<br>* Other names: Flexitouch system;Drug: NIRFLI with ICG<br>* Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.<br>* Other names: Near Infrared Fluorescence Imaging with Indocyanine Green;|
| Experimental: Pneumatic Compression-2 sessions per day<br>Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green). | Device: Head and neck garments for pneumatic compression device<br>* Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds; and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema<br>* Other names: Flexitouch system;Drug: NIRFLI with ICG<br>* Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.<br>* Other names: Near Infrared Fluorescence Imaging with Indocyanine Green;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph Movement Measured by ICG Lymphography. | 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. | Single Treatment, 2 Weeks of Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermal Backflow Measured by ICG Lymphography. | 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. | Single Treatment, 2 Weeks of Treatment | 
| Symptom Alleviation Measured by Survey Response. | Alleviates lymphedema symptoms as measured by survey response. | Single Treatment, 2 Weeks of Treatment | 
| Ease of Use Measured by Survey Response. | Flexitouch is easy to use as measured by survey responses. | Single Treatment, 2 Weeks of Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, Cancer, Head Cancer, Neck Cancer