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

November 14, 2022 updated by: Tactile Medical

A Randomized, Single-Center Study to Determine Swallow Outcomes in Subjects With Head and Neck Lymphedema Receiving Early Intervention With Pneumatic Compression

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University Of California - Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: FT-CC and Swallow Exercises
Device: FT-CC and Swallow Exercises
Once daily treatment with FT Plus with investigational connectivity software and standard of care swallow exercises.
ACTIVE_COMPARATOR: Swallow Exercises
Other: Swallow Exercises
Standard of care swallow exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Swallow outcomes via modified barium swallow - Penetration-Aspiration Scale (PAS)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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.
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Swallow outcomes via modified barium swallow - Pharyngeal Constriction Ratio (PCR)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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.
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Swallow outcomes via modified barium swallow - Upper Esophageal Sphincter Opening (UESmax)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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.
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Swallow outcomes via modified barium swallow - Esophageal Bolus Transit Time (ETT)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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).
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Swallow outcomes via modified barium swallow - Normalized residue ratio scale (NRRS)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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.
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Swallow outcomes via modified barium swallow - Posterior Pharyngeal Wall Thickness (PPW)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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)
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Function - Stimulated Saliva Secretion Rate
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Stimulated Saliva Secretion Rate is the measure of total saliva collected in 3 minutes while chewing gum.
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Swallow outcomes via patient reported outcome measure - Eating Assessment Tool (EAT-10) Questionnaire Score
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Min value = 0, max value = 4. The lower the score the better the outcome.
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Patient Reported Function - Voice Handicap Index (VHI-10)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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.
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Patient Reported Function - Functional Assessment of Cancer Therapy - Head and Neck (FACT HN)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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.
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Nutrition - Weight
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Weight
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Nutrition - Body Mass Index (BMI)
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
BMI
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Complications - Treatment Interruptions
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Number/days of treatment interruptions
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Complications - Hospitalizations
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Number/days of hospitalizations
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Complications - Pulmonary Infections
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Number/days of pulmonary infections
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Complications - Adverse Events
Time Frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Total number of adverse events
Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PET Measurements - Epiglottic Thickness
Time Frame: Changes between Baseline and 12-Week Follow-Up
A measurement of the epiglottic thickness.
Changes between Baseline and 12-Week Follow-Up
PET Measurements - Prevertebral Space
Time Frame: Changes between Baseline and 12-Week Follow-Up
A measurement of the prevertebral space.
Changes between Baseline and 12-Week Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tactile Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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