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

Overview

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.

Full Title of Study: “Assessment of Lymphatic Structure and Function Pre- and Post- Treatment and During Recovery in Head and Neck Cancer Patients Using NIR Fluorescence Lymphatic Imaging”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2018

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Lymph Movement Measured by ICG Lymphography.
    • Time Frame: 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 Measures

  • Dermal Backflow Measured by ICG Lymphography.
    • Time Frame: 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.
    • Time Frame: Single Treatment, 2 Weeks of Treatment
    • Alleviates lymphedema symptoms as measured by survey response.
  • Ease of Use Measured by Survey Response.
    • Time Frame: Single Treatment, 2 Weeks of Treatment
    • Flexitouch is easy to use as measured by survey responses.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tactile Medical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John Rasmussen, PhD, Principal Investigator, The University of Texas Health Science Center, Houston

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