Head and Neck LymphedemaNCT04335981
Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression
A study testing FT-CC and Swallow Exercises and Swallow Exercises in people with Head and Neck Lymphedema, run by Tactile Medical at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Lymphedema
- What is being tested?
- FT-CC and Swallow Exercises and Swallow Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California - Davis
Sacramento, California, 95817
About this study
Official title: 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.
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.
- Conditions
- Head and Neck Lymphedema
- Being tested
- FT-CC and Swallow Exercises, Swallow Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT-CC and Swallow ExercisesDevice
Once daily treatment with FT Plus with investigational connectivity software and standard of care swallow exercises.
Swallow ExercisesOther
Standard of care swallow exercises.
| Study group | Role | What they receive |
|---|---|---|
| FT-CC and Swallow Exercises | Experimental | Not described Receives: Device: FT-CC and Swallow Exercises |
| Swallow Exercises | Active comparator | Not described Receives: Other: Swallow Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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)
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Function - Stimulated Saliva Secretion Rate
Stimulated Saliva Secretion Rate is the measure of total saliva collected in 3 minutes while chewing gum.
Measured: 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
Min value = 0, max value = 4. The lower the score the better the outcome.
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
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.
Measured: 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)
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.
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Nutrition - Weight
Weight
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Nutrition - Body Mass Index (BMI)
BMI
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Complications - Treatment Interruptions
Number/days of treatment interruptions
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Complications - Hospitalizations
Number/days of hospitalizations
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Complications - Pulmonary Infections
Number/days of pulmonary infections
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Complications - Adverse Events
Total number of adverse events
Measured: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start24 Sep 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: Slower than anticipated enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335981
- Sponsor's protocol ID
- 8020
- Status last verified
- Nov 2022
- First submitted
- 10 Mar 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Center Study to Determine Swallow Outcomes in Subjects With Head and Neck Lymphedema Receiving Early Intervention With Pneumatic Compression
- ClinicalTrials.gov ID
- NCT04335981
- Acronym / sponsor ID
- 8020
- Conditions
- Head and Neck Lymphedema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than anticipated enrollment.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FT-CC and Swallow Exercises | Experimental | Device: FT-CC and Swallow Exercises |
| Swallow Exercises | Active comparator | Other: Swallow Exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT-CC and Swallow ExercisesOnce daily treatment with FT Plus with investigational connectivity software and standard of care swallow exercises. | Device | FT-CC and Swallow Exercises |
| Swallow ExercisesStandard of care swallow exercises. | Other | Swallow Exercises |
Primary outcome
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.
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.
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.
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).
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.
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)
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.
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.
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.
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.
Nutrition - Weight
Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Weight
Nutrition - Body Mass Index (BMI)
Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
BMI
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
Complications - Hospitalizations
Time frame: Changes between Baseline, 6-Week Follow-Up, 12-Week Follow-Up, and 18-Week Follow-Up
Number/days of hospitalizations
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
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
Results and safety
The study was stopped early (reason given: Slower than anticipated enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FT-CC and Swallow Exercises and Swallow Exercises in people with Head and Neck Lymphedema, run by Tactile Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slower than anticipated enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.