Clinical Trial TitleA Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema
National Clinical Trial Number:NCT04797390
Clinical Trial Protocol Description:
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.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age.
- Have pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary).
- Have completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment.
- Have a diagnosis of either internal or external head and neck lymphedema.
You will be excluded from the study if any of the following criteria apply to you:
- Have had previous APCD or Usual Care treatment for HNC LEF.
- Have acute facial infection (e.g., facial or parotid gland abscess).
- Have known carotid sinus hypersensitivity syndrome.
- Have 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).
- Have internal jugular venous thrombosis (within 3 months).
- Are pregnant or trying to become pregnant.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.