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Completed

NCT Number: NCT02946021

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

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.

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Key information

Conditions

Head and Neck Neoplasms Head and Neck Cancer Head and Neck Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UT Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head and neck garments for pneumatic compression device

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

Other names: Flexitouch system

NIRFLI with ICG

Drug

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.

Other names: Near Infrared Fluorescence Imaging with Indocyanine Green

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Symptom Alleviation Measured by Survey Response.

    Time frame: Single Treatment, 2 Weeks of Treatment

    Alleviates lymphedema symptoms as measured by survey response.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tactile Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2016
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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