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

Tactile Medical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Head and Neck Neoplasms; Head and Neck Cancer; Head and Neck Lymphedema

Treatments: Drug: NIRFLI with ICG; Device: Head and neck garments for pneumatic compression device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02946021

HSC-MS-16-0465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Pneumatic Compression-1 session per day

Experimental group

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).

Treatment:

Device: Head and neck garments for pneumatic compression device

Drug: NIRFLI with ICG

Pneumatic Compression-2 sessions per day

Experimental group

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).

Treatment:

Device: Head and neck garments for pneumatic compression device

Drug: NIRFLI with ICG