Are you currently undergoing radiation treatment for Head and Neck Cancer?
This may help reduce post-radiation swelling known to cause swallowing issues.
a study on Head and Neck Lymphedema Head and Neck Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis
- Dates
- study startedestimated completion
Description
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) measurements, function, and complication rate post-radiotherapy in subjects treated for oropharyngeal cancer.
Official Title
A Randomized, Single-Center Study to Determine Swallow Outcomes in Subjects With Head and Neck Lymphedema Receiving Early Intervention With Pneumatic Compression
Details
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 subjects who provide consent and meet the eligibility criteria following completion of radiotherapy will begin a 6 weeks regimen of in-home swallow exercises. They will then return to the clinic for final screening and randomization into one of two treatment groups: Flexitouch Plus Cellular Connectivity (FT-CC) and Swallow Exercises (Intervention) or Swallow Exercises alone (Standard Care). A total of 3 in-clinic visits and 1 phone call will be conducted over a 12-week period. The Standard Care group will be offered an optional 6 week follow-up period to use the device in-home and will be seen in the clinic for one additional follow-up Visit 2. A reading center with personnel blinded to treatment assignment will be used to interpret the MBS and PET study results.
Keywords
Head and Neck Lymphedema Lymphedema FT-CC and Swallow Exercises Swallow Exercises
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- 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
Location
- University of California - Davis
accepting new patients
Sacramento California 95817 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Tactile Medical
- ID
- NCT04335981
- Study Type
- Interventional
- Last Updated