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TerminatedNCT04335981Updated Nov 17, 2022

Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression

An interventional study of FT-CC and Swallow Exercises and Swallow Exercises in Head and Neck Lymphedema, sponsored by Tactile Medical. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by Tactile Medical · Not applicable, Interventional, and Treatment

Why this study was terminated
Slower than anticipated enrollment.

From the registry’s dates

  • Primary completion was Oct 2022, 4 years ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Head and Neck Lymphedema

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03

In context

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's enrollment of 22 is below the median of 50 across 403 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Tactile Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    FT-CC and Swallow Exercises

    Device: FT-CC and Swallow Exercises

  • Active comparator
    Swallow Exercises

    Other: Swallow Exercises

Interventions

  • DeviceFT-CC and Swallow Exercises

    Once daily treatment with FT Plus with investigational connectivity software and standard of care swallow exercises.

  • OtherSwallow Exercises

    Standard of care swallow exercises.

06

What researchers measure

Primary outcomes

  1. Swallow outcomes via modified barium swallow - Penetration-Aspiration Scale (PAS)

    PAS is an eight-point ordinal severity scale scoring the depth of airway invasion by the bolus, whether it is expelled from the airway as well as any patient reaction. It ranges from one (material does not enter the airway) to eight (material enters the airway, passes below the vocal folds, and no effort is made to eject). Min value = 1, Max value = 8, the lower the score the better.

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  2. Swallow outcomes via modified barium swallow - Pharyngeal Constriction Ratio (PCR)

    PCR is calculated by dividing the pharyngeal area (cm2) of the bolus hold frame (PAHOLD) by the maximum pharyngeal contraction frames (PAMAX). Min value = 0, Max value = 1. The lower the score, the better the outcome.

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  3. Swallow outcomes via modified barium swallow - Upper Esophageal Sphincter Opening (UESmax)

    UES measurements will include the: (1) maximum width of the UES opening as defined by the line between the anterior and posterior walls of the pharyngoesophageal segment at its narrowest area during its maximum opening in a lateral view, and (2) the maximum width of the UES opening as viewed anteriorly. Min value = 0, max value = 2. Greater the score, the better the outcome.

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  4. Swallow outcomes via modified barium swallow - Esophageal Bolus Transit Time (ETT)

    The time it takes the bolus to get through the cricopharyngeal muscle (where the esophageal phase is initiated) to the bottom of the esophagus (at the junction of the lower esophageal sphincter). Min value = 0, max value = 60. The lower the score, the better the outcome (seconds).

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  5. Swallow outcomes via modified barium swallow - Normalized residue ratio scale (NRRS)

    Pharyngeal residue is the term used to describe material that remains in the pharynx post swallow (also called retention or stasis). The NRRS is calculated using ImageJ pixel area measures of residue in the valleculae. Min value = 0, max value = 1. The lower the score, the better the outcomes.

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  6. Swallow outcomes via modified barium swallow - Posterior Pharyngeal Wall Thickness (PPW)

    PPW is the thickness of the posterior pharyngeal wall in lateral view while holding a 1-ml liquid bolus in oral cavity prior to swallow (PPWhold). Min value = 0, max value = 30. The lower the score the better the outcomes (mm)

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  7. Function - Stimulated Saliva Secretion Rate

    Stimulated Saliva Secretion Rate is the measure of total saliva collected in 3 minutes while chewing gum.

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  8. Swallow outcomes via patient reported outcome measure - Eating Assessment Tool (EAT-10) Questionnaire Score

    Min value = 0, max value = 4. The lower the score the better the outcome.

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  9. Patient Reported Function - Voice Handicap Index (VHI-10)

    A survey that quantifies the functional, physical, and emotional impacts of a voice disorder on a subject's quality of life. It captures the subject's subjective rating of a series of 10 questions. Min value = 0, max value = 40. The lower the score the better the outcomes.

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  10. Patient Reported Function - Functional Assessment of Cancer Therapy - Head and Neck (FACT HN)

    A survey which inquires on a series of concerns related to the head and neck region including oral comfort, breathing, voice, eating, appearance, tobacco, alcohol, and communication. The subject is asked to indicate how important each of the 39 listed concerns have been in the past 7 days. Min value = 0, max value = 148. The higher the score the better the quality of life.

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  11. Nutrition - Weight

    Weight

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  12. Nutrition - Body Mass Index (BMI)

    BMI

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  13. Complications - Treatment Interruptions

    Number/days of treatment interruptions

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  14. Complications - Hospitalizations

    Number/days of hospitalizations

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  15. Complications - Pulmonary Infections

    Number/days of pulmonary infections

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

  16. Complications - Adverse Events

    Total number of adverse events

    Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

Other outcomes

  1. PET Measurements - Epiglottic Thickness

    A measurement of the epiglottic thickness.

    Time frame: Changes between Baseline and 12-Week Follow-Up

  2. PET Measurements - Prevertebral Space

    A measurement of the prevertebral space.

    Time frame: Changes between Baseline and 12-Week Follow-Up

07

Study locations

1 site
  • University of California - Davis
    Sacramento, California 95817, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04335981
Lead sponsor
Tactile Medical
Responsible party
Sponsor
First posted
Apr 7, 2020
Start date
Sep 24, 2020
Primary completion
Oct 1, 2022
Completion
Oct 1, 2022
Last update
Nov 17, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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