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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Head and neck garments for pneumatic compression device
NIRFLI with ICG
Sponsored by
Tactile Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Lymphedema, Cancer, Head Cancer, Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pneumatic Compression-1 session per day

Pneumatic Compression-2 sessions per day

Arm Description

Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).

Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Symptom Alleviation Measured by Survey Response.
Alleviates lymphedema symptoms as measured by survey response.
Ease of Use Measured by Survey Response.
Flexitouch is easy to use as measured by survey responses.

Full Information

First Posted
October 20, 2016
Last Updated
March 28, 2019
Sponsor
Tactile Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02946021
Brief Title
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tactile Medical

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Head and Neck Lymphedema, Head and Neck Cancer
Keywords
Lymphedema, Cancer, Head Cancer, Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pneumatic Compression-1 session per day
Arm Type
Experimental
Arm Description
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
Arm Title
Pneumatic Compression-2 sessions per day
Arm Type
Experimental
Arm Description
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
Intervention Type
Device
Intervention Name(s)
Head and neck garments for pneumatic compression device
Other Intervention Name(s)
Flexitouch system
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
NIRFLI with ICG
Other Intervention Name(s)
Near Infrared Fluorescence Imaging with Indocyanine Green
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lymph Movement Measured by ICG Lymphography.
Description
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.
Time Frame
Single Treatment, 2 Weeks of Treatment
Secondary Outcome Measure Information:
Title
Dermal Backflow Measured by ICG Lymphography.
Description
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.
Time Frame
Single Treatment, 2 Weeks of Treatment
Title
Symptom Alleviation Measured by Survey Response.
Description
Alleviates lymphedema symptoms as measured by survey response.
Time Frame
Single Treatment, 2 Weeks of Treatment
Title
Ease of Use Measured by Survey Response.
Description
Flexitouch is easy to use as measured by survey responses.
Time Frame
Single Treatment, 2 Weeks of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Rasmussen, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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