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

NCT ID: NCT02946021

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-02-28

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.

Conditions

Head and Neck Neoplasms; Head and Neck Lymphedema; Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Head and neck garments for pneumatic compression device

Intervention Type: 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

NIRFLI with ICG

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Head and neck garments for pneumatic compression device

Intervention Type: 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

NIRFLI with ICG

Intervention Type: 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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

Flexitouch system; Near Infrared Fluorescence Imaging with Indocyanine Green

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tactile Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Rasmussen, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

UT Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-16-0465

Identifier Type: -

Identifier Source: org_study_id