Terminated
NA
INTERVENTIONAL
NCT04335981
Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
FT-CC and Swallow Exercises
Type:
DEVICE
Description:
Once daily treatment with FT Plus with investigational connectivity software and standard of care swallow exercises.
Name:
Swallow Exercises
Type:
OTHER
Description:
Standard of care swallow exercises.
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
Description:
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.
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
Description:
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.
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
Description:
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.
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
Description:
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).
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
Description:
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.
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
Description:
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)
Measure:
Function - Stimulated Saliva Secretion Rate
TimeFrame:
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Description:
Stimulated Saliva Secretion Rate is the measure of total saliva collected in 3 minutes while chewing gum.
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
Description:
Min value = 0, max value = 4. The lower the score the better the outcome.
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
Description:
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.
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
Description:
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.
Measure:
Nutrition - Weight
TimeFrame:
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Description:
Weight
Measure:
Nutrition - Body Mass Index (BMI)
TimeFrame:
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Description:
BMI
Measure:
Complications - Treatment Interruptions
TimeFrame:
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Description:
Number/days of treatment interruptions
Measure:
Complications - Hospitalizations
TimeFrame:
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Description:
Number/days of hospitalizations
Measure:
Complications - Pulmonary Infections
TimeFrame:
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Description:
Number/days of pulmonary infections
Measure:
Complications - Adverse Events
TimeFrame:
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Description:
Total number of adverse events
Trial Information
NCT ID
NCT04335981
Status
Terminated
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Tactile Medical
Last Updated
December 15, 2025