Status:
COMPLETED
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
Lead Sponsor:
Tactile Medical
Collaborating Sponsors:
Vanderbilt University Medical Center
Conditions:
Lymphedema
Lymphedema of Face
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.
Detailed Description
Aim 1: To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on anatomical measures of internal and exter...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary)
- Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment
- A diagnosis of either internal or external head and neck lymphedema
- At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening
- Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation
- Must be able to speak and understand English
Exclusion
- Previous APCD or Usual Care treatment for HNC LEF
- Acute facial infection (e.g., facial or parotid gland abscess)
- Known 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)
- Internal jugular venous thrombosis (within 3 months)
- Patient is pregnant or trying to become pregnant
Key Trial Info
Start Date :
September 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04797390
Start Date
September 23 2021
End Date
March 31 2025
Last Update
June 8 2025
Active Locations (10)
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1
University of Alabama
Birmingham, Alabama, United States, 35924
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
University of Louisville
Louisville, Kentucky, United States, 40202
4
Johns Hopkins University
Baltimore, Maryland, United States, 21205