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New rehab program aims to ease hidden side effects of head and neck cancer treatment

NCT ID NCT07622407

Symptom relief Sponsor: VA Office of Research and Development 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests a coordinated rehab program for 74 veterans with head and neck cancer. The program combines standard swallowing therapy with proactive hearing and balance checks and a nurse assessment to find other rehab needs. The goal is to reduce stress and improve well-being compared to swallowing therapy alone.

What this could mean

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

Active substance
coordinated rehabilitation program (swallowing therapy, hearing/balance management, and tele-oncology nurse assessment)
What this could lead to
If successful, this program could reduce stress and improve quality of life for head and neck cancer survivors by catching hearing and balance problems early.
What could go wrong
This is a small early-stage trial (74 participants) at two VA sites, so results may not apply to all patients. The program adds extra steps, which may not be feasible everywhere.

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

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 89 years

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: * diagnosed with head and neck malignancy within the past 60 days; * prescribed a treatment plan at participating site that includes at least 1 dose of a cisplatin-based chemotherapy, or at least one dose of radiotherapy and/or surgery; * prescribed Intensive Dysphagia Therapy (IDT) at the participating site; * sufficient fluency in written English to be able to complete the study patient reported outcome questionnaires. Exclusion Criteria: Participants will be excluded is they have: * distant metastasis at enrollment; * diagnosis of second primary non-head and neck cancer in the thorax or the central nervous system at enrollment; * prior or planned total laryngectomy; * prior or planned cochlear implant; * head and neck radiotherapy for thyroid or cutaneous/skin primary tumors, regardless of neck fields; * cognitively or physically unable to participate (patient, physician or nurse report patient is incapable of participating), medical records indicate that participant exhibits aggressive behavior, participant has documented dementia, Alzheimer's disease, or severe psychosocial disorder, or notes indicate an individual is not legally capable of providing informed consent (participant has a legal guardian); * moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade \>=2; * severe/profound hearing loss at enrollment per baseline audiogram; * exhibits Meniere's disease or retrocochlear disorder based on baseline hearing test results, patient report or notes in electronic medical records; * exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, baseline hearing test results, patient report, or medical record documentation; * unwilling to participate.

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders Drug-Related Side Effects and Adverse Reactions head and neck cancer Head and Neck Neoplasms hearing loss disorder Hearing Loss, Sensorineural Ototoxicity tinnitus

As listed by the trial registrant

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

Dysphagia Head and neck cancer Hearing loss Tinnitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875, United States

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964, United States

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    Madison, Wisconsin, 53705-2254, United States

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