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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946021
• Other study ID #: HSC-MS-16-0465
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2019
• Source: Tactile Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Lymphedema
• Head and Neck Neoplasms
• Lymphedema

Intervention

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

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.

Locations

Country	Name	City	State
United States	UT Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Single Treatment, 2 Weeks of Treatment
Secondary	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.	Single Treatment, 2 Weeks of Treatment
Secondary	Symptom Alleviation Measured by Survey Response.	Alleviates lymphedema symptoms as measured by survey response.	Single Treatment, 2 Weeks of Treatment
Secondary	Ease of Use Measured by Survey Response.	Flexitouch is easy to use as measured by survey responses.	Single Treatment, 2 Weeks of Treatment