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New device may ease swelling in head and neck cancer survivors

NCT ID NCT04797390

Symptom relief Sponsor: Tactile Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether an advanced pneumatic compression device (Flexitouch Plus) could reduce swelling and symptoms in 236 head and neck cancer survivors with lymphedema. Participants either used the device daily or received usual care like manual drainage and compression garments. The trial measured changes in internal and external swelling, symptom burden, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Advanced Pneumatic Compression Device (Flexitouch Plus)
What this could lead to
If it works, this could offer a more effective way to reduce swelling and improve quality of life for head and neck cancer survivors with lymphedema.
What could go wrong
This is a completed trial, but results may not apply to all patients. The device is an add-on to usual care, not a standalone cure, and benefits may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

236 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary) 3. Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment 4. A diagnosis of either internal or external head and neck lymphedema 5. At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening 6. Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation 7. Must be able to speak and understand English Exclusion Criteria: 1. Previous APCD or Usual Care treatment for HNC LEF 2. Acute facial infection (e.g., facial or parotid gland abscess) 3. Known carotid sinus hypersensitivity syndrome 4. 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) 5. Internal jugular venous thrombosis (within 3 months) 6. Patient is pregnant or trying to become pregnant

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Conditions

The condition(s) this trial relates to.

head and neck cancer lymphedema Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphedema Lymphedema due to radiation Lymphedema of face Lymphedema, secondary Lymphedema; surgical

Contacts and locations

Locations

  • Advanced Head & Neck Rehabilitation Center of Texas

    Fort Worth, Texas, 76104, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Richmond University Medical Center

    Staten Island, New York, 10310, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • University of Alabama

    Birmingham, Alabama, 35924, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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