Status:
TERMINATED
Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression
Lead Sponsor:
Tactile Medical
Conditions:
Head and Neck Lymphedema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to assess the effect early pneumatic compression (prior to confirming cancer-free status via PET or CT imaging) has on swallow outcomes, positron emission tomography (PET...
Detailed Description
This is a single-center, prospective, randomized, two-arm, wait-list control study that plans to enroll a total of 24 subjects in the United States. A baseline screening will take place where all subj...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- A previous diagnosis of oropharyngeal carcinoma requiring treatment with radiation therapy
- Diagnosis/evidence of lymphedema stage 1a or higher by clinical presentation based upon MD Anderson Cancer Center Head and Neck Lymphedema rating scale
- EAT-10 score \>4 at Baseline and Randomization Visits (prior to randomizing subject)
- 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)
- Ability to perform swallow exercises
- Willing and able to comply with the study protocol requirements and all study-related visit requirements
- Willing and able to provide informed consent prior to study participation
Exclusion
- Synchronous treatment for cancer (may or may not have successfully complete prior cancer treatment)
- Other known causes of dysphagia such as previous radiation to the head and neck, or neuromuscular or neurodegenerative known to have a strong association with dysphagia (i.e., Parkinsons, ALS, MS, OPMD)
- Poorly controlled: kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism or parathyroidism, cyclic edema, or Munchausen Syndrome (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 (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 wounds, surgical flap less than 6-8 weeks post-operative
- Facial or head and neck dermal metastasis
- Acute infection/inflammatory disease of the head and neck region (e.g., facial infection, parotid gland abscess, acute cellulitis, or other uncontrolled skin/untreated head and neck inflammatory skin disease)
- Any condition in which increased venous and lymphatic return is undesirable
- Heart failure (acute pulmonary edema, decompensated acute heart failure)
- Subject is pregnant or trying to become pregnant
- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 1½ months
- Any subject who is considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
- The subject has participated in any investigational drug or device research study within 30 days of enrollment
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04335981
Start Date
September 24 2020
End Date
October 1 2022
Last Update
November 17 2022
Active Locations (1)
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1
University of California - Davis
Sacramento, California, United States, 95817