Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03332160
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* A previous diagnosis of histologically defined head and neck cancer.
* A diagnosis of head and neck lymphedema.
* Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation.
* Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved.
* The head and neck garments must fit appropriately. For patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy.
* The subject must have experienced at least one of the following:
* Completion of phase 1 lymphedema care in the past 8 weeks;
* The inability to participate/complete phase 1 care due to:
* Lack of available therapist/clinic,
* Lack of insurance coverage or funding to support cost of care.
Exclusion Criteria:
* Uncontrolled hyperthyroidism or parathyroidism (for which 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.
* Increased intracranial pressure or other contraindications 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 in which increased venous and lymphatic return is undesirable.
* History of pulmonary edema or decompensated congestive heart failure with in six (6) week of enrollment.
* Subject is pregnant or trying to become pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03332160
Study Brief:
Protocol Section:
NCT03332160