TerminatedNot Applicable

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

Stopped: Slower than anticipated enrollment.

United States22 participantsStarted 2020-09-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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

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

Trial details

NCT IDNCT04335981

SponsorTactile Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-01

View on ClinicalTrials.gov More Head and Neck Lymphedema trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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