Clinical trial NCT04335981: Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression
Official title: A Randomized, Single-Center Study to Determine Swallow Outcomes in Subjects With Head and Neck Lymphedema Receiving Early Intervention With Pneumatic Compression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Lymphedema
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2020-04-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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) measurements, function, and complication rate post-radiotherapy in subjects treated for oropharyngeal cancer.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. A previous diagnosis of oropharyngeal carcinoma requiring treatment with radiation therapy
3. Diagnosis/evidence of lymphedema stage 1a or higher by clinical presentation based upon MD Anderson Cancer Center Head and Neck Lymphedema rating scale
4. EAT-10 score \>4 at Baseline and Randomization Visits (prior to randomizing subject)
5. 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)
6. Ability to perform swallow exercises
7. Willing and able to comply with the study protocol requirements and all study-related visit requirements
8. Willing and able to provide informed consent prior to study participation

Exclusion Criteria:

1. Synchronous treatment for cancer (may or may not have successfully complete prior cancer treatment)
2. 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)
3. 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)
4. Carotid sinus hypersensitivity syndrome
5. 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)
6. Symptomatic bradycardia in the absence of a pacemaker
7. Internal jugular venous thrombosis (within 3 months)
8. Increased intracranial pressure or other contraindications to internal or external jugular venous compression
9. Acute radiation dermatitis, unhealed surgical scar, unhealed or open wounds, surgical flap less than 6-8 weeks post-operative
10. Facial or head and neck dermal metastasis
11. 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)
12. Any condition in which increased venous and lymphatic return is undesirable
13. Heart failure (acute pulmonary edema, decompensated acute heart failure)
14. Subject is pregnant or trying to become pregnant
15. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
16. 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
17. Any subject who is considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
18. The subject has participated in any investigational drug or device research study within 30 days of enrollment

Primary outcomes:
measure: Swallow outcomes via modified barium swallow - Penetration-Aspiration Scale (PAS)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Swallow outcomes via modified barium swallow - Pharyngeal Constriction Ratio (PCR)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Swallow outcomes via modified barium swallow - Upper Esophageal Sphincter Opening (UESmax)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Swallow outcomes via modified barium swallow - Esophageal Bolus Transit Time (ETT)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Swallow outcomes via modified barium swallow - Normalized residue ratio scale (NRRS)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Swallow outcomes via modified barium swallow - Posterior Pharyngeal Wall Thickness (PPW)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Function - Stimulated Saliva Secretion Rate
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Swallow outcomes via patient reported outcome measure - Eating Assessment Tool (EAT-10) Questionnaire Score
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Patient Reported Function - Voice Handicap Index (VHI-10)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Patient Reported Function - Functional Assessment of Cancer Therapy - Head and Neck (FACT HN)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Nutrition - Weight
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Nutrition - Body Mass Index (BMI)
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Complications - Treatment Interruptions
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Complications - Hospitalizations
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Complications - Pulmonary Infections
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
measure: Complications - Adverse Events
timeFrame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Secondary outcomes:
Other outcomes:
measure: PET Measurements - Epiglottic Thickness
timeFrame: Changes between Baseline and 12-Week Follow-Up
measure: PET Measurements - Prevertebral Space
timeFrame: Changes between Baseline and 12-Week Follow-Up
Locations:
city: Sacramento
country: United States
facility: University of California - Davis
state: California
Study officials:
References: