Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Tactile Medical

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946021


Locations
Layout table for location information
United States, Texas
UT Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Tactile Medical
Investigators
Layout table for investigator information
Principal Investigator: John Rasmussen, PhD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Tactile Medical:
Layout table for additonal information
Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT02946021    
Other Study ID Numbers: HSC-MS-16-0465
First Posted: October 26, 2016    Key Record Dates
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:
Layout table for MeSH terms
Head and Neck Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Lymphatic Diseases