Phase 2
N=11
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema
Head and Neck Neoplasms · Head and Neck Lymphedema · Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02946021 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Lymph Movement Measured by ICG Lymphography. — 5; 5; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Head and neck garments for pneumatic compression device (Device); NIRFLI with ICG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tactile Medical
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lymph Movement Measured by ICG Lymphography. |
5; 5; 0; 0; 5; 4 | — |
| SECONDARY Dermal Backflow Measured by ICG Lymphography. |
4; 4; 0; 0; 1; 1 | — |
| SECONDARY Symptom Alleviation Measured by Survey Response. |
0; 2; 4; 2; 1; 1 | — |
| SECONDARY Ease of Use Measured by Survey Response. |
1; 1; 4; 4; 0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02946021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.