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

• ClinicalTrials.gov Identifier: NCT02946021
• Recruitment Status: Completed
• First Posted: October 26, 2016
• Results First Posted: March 20, 2019
• Last Update Posted: April 9, 2019
• Sponsor: Tactile Medical
• Information provided by (Responsible Party): Tactile Medical

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Neoplasms; Head and Neck Lymphedema; Head and Neck Cancer	Device: Head and neck garments for pneumatic compression device; Drug: NIRFLI with ICG	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: February 2018
• Actual Study Completion Date: February 2018

Arms and Interventions

Arm	Intervention/treatment
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).	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; Other Name: Flexitouch system; 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.; Other Name: Near Infrared Fluorescence Imaging with 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).	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; Other Name: Flexitouch system; 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.; Other Name: Near Infrared Fluorescence Imaging with Indocyanine Green

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

UT Health Science Center at Houston

Houston, Texas, United States, 77030

Sponsors and Collaborators

Tactile Medical

Investigators

• Principal Investigator: John Rasmussen, PhD; The University of Texas Health Science Center, Houston

  Study Documents (Full-Text)

Documents provided by Tactile Medical:

Study Protocol and Statistical Analysis Plan  [PDF] December 4, 2017

More Information

• Responsible Party: Tactile Medical
• ClinicalTrials.gov Identifier: NCT02946021
• Other Study ID Numbers: HSC-MS-16-0465
• First Posted: October 26, 2016
• Results First Posted: March 20, 2019
• Last Update Posted: April 9, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Tactile Medical:

Lymphedema; Cancer; Head Cancer; Neck Cancer

Additional relevant MeSH terms:

Head and Neck Neoplasms; Lymphedema; Neoplasms by Site; Neoplasms; Lymphatic Diseases