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Early treatment may stop swelling in head and neck cancer survivors

NCT ID NCT05937269

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests whether starting physiotherapy early—before any swelling appears—can prevent lymphedema in people treated for head and neck cancer. Twenty participants will either use a home compression device daily or receive standard care. Researchers will track swelling and use special imaging to see if early treatment makes a difference.

What this could mean

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

Active substance
pneumatic compression therapy
What this could lead to
If it works, this could prevent lymphedema in head and neck cancer survivors, avoiding painful swelling and improving quality of life.
What could go wrong
This is a very small early-phase trial with only 20 participants, so results may not apply to everyone. The treatment requires daily home use, which may be hard to maintain.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Participants must be 18 years of age or older * Participants must have previously been diagnosed with head and neck cancer and undergone surgery and radiation as part of their standard-of-care treatment plan * Participants must be ≥ 4 weeks but less than 3 months post-radiation therapy at enrollment * Female participants of childbearing potential must have a negative urine pregnancy test ≤ 36 hours prior to study drug administration * Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month after each imaging session * Male participants must agree to shave facial hair on imaging days * Participants must be willing and able to independently use the pneumatic compression device at home daily for up to 12 months as directed by study personnel. Exclusion Criteria: * Persons who are pregnant or breast-feeding * Females of child-bearing potential, who do not agree to use an approved contraceptive for one month after each imaging session * Persons who do not meet inclusion criteria * Iodine allergy * Persons with a chest circumference of 150 cm or more * Uncontrolled hyperthyroidism or parathyroidism (for which an 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 or internal jugular venous thrombosis (within 3 months) * Increased intracranial pressure or other contraindication to internal or external jugular venous compression * Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6 to 8-weeks post-operative * Facial or head and neck dermal metastasis * Acute facial infection (e.g., facial, or parotid gland abscess) * Heart failure (acute pulmonary edema, decompensated acute heart failure) * Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) * Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene) * Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin, or untreated inflammatory skin disease) * Any condition where increased venous and lymphatic return is undesirable

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.