Clinical trial NCT02946021: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Neoplasms
Head and Neck Lymphedema
Head and Neck Cancer
Keywords: Lymphedema
Cancer
Head Cancer
Neck Cancer
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2016-10-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lymph Movement Measured by ICG Lymphography.
timeFrame: Single Treatment, 2 Weeks of Treatment
Secondary outcomes:
measure: Dermal Backflow Measured by ICG Lymphography.
timeFrame: Single Treatment, 2 Weeks of Treatment
measure: Symptom Alleviation Measured by Survey Response.
timeFrame: Single Treatment, 2 Weeks of Treatment
measure: Ease of Use Measured by Survey Response.
timeFrame: Single Treatment, 2 Weeks of Treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: John Rasmussen, PhD
role: PRINCIPAL_INVESTIGATOR
References: