Clinical trial · Interventional
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema
Assessment of Lymphatic Structure and Function Pre- and Post- Treatment and During Recovery in Head and Neck Cancer Patients Using NIR Fluorescence Lymphatic Imaging
NCT02946021CI-TRIAL-00038019completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Lymphedema | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Head and neck garments for pneumatic compression device | Device | — | UNRESOLVED |
| NIRFLI with ICG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pneumatic Compression-1 session per day
- 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).
- interventionNames
- Device: Head and neck garments for pneumatic compression device
- Drug: NIRFLI with ICG
- type
- EXPERIMENTAL
- label
- Pneumatic Compression-2 sessions per day
- 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).
- interventionNames
- Device: Head and neck garments for pneumatic compression device
- Drug: NIRFLI with ICG
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.