A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
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.
fibrosis (LEF) in head and neck cancer (HNC) survivors.
Head/Neck
N/A
Adults
Supportive Care
Not Available
Murphy, Barbara
National
Vanderbilt University
09-13-2021
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
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 Criteria:
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
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 Criteria:
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
