Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07264036

Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study

Led by Vanessa Torrecillas · Updated on 2026-04-28

20

Participants Needed

1

Research Sites

66 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Some head and neck cancer survivors develop velopharyngeal dysfunction (VPD), a problem with closure between the soft palate and throat that can cause nasal-sounding speech, food or liquid leaking into the nose, difficulty swallowing, and reduced quality of life. This study aims to better understand VPD in this population and to evaluate whether pharyngeal wall augmentation (plumping up the back wall of the throat) can improve speech and swallowing. Participants will undergo a multidisciplinary assessment including physical examination, flexible nasolaryngoscopy, speech recording and acoustic analysis, nasometry, clinical swallowing evaluation, and fiberoptic endoscopic evaluation of swallowing (FEES). Aim 1: Determine the prevalence, severity, and functional impact of VPD in head and neck cancer survivors. Aim 2: Assess the feasibility and usefulness of advanced diagnostic tools for VPD. The investigators hypothesize that high nasalance scores (\>1 SD above normal) will accurately predict VPD with at least 75% positive predictive value and will correlate with worse communication-related quality of life (CPIB). The investigators also hypothesize that participants with VPD will have more pharyngeal residue or nasal regurgitation on FEES, and that these findings will be associated with lower swallowing-related quality of life (SWAL-QOL). Aim 3: Evaluate the effectiveness of pharyngeal wall augmentation injections for improving speech intelligibility and swallowing function. The investigators expect that this treatment will lead to measurable changes in both objective assessments and patient-reported outcomes. The results will help improve diagnosis and management of VPD in head and neck cancer survivors.

CONDITIONS

Official Title

Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking adults 18 years or older
  • History of head and neck cancer treated with surgery, chemoradiation, or both
  • Presence of nasal-sounding speech (perceptual hypernasality) on clinical assessment
Not Eligible

You will not qualify if you...

  • Pre-existing or suspected non-cancer-related velopharyngeal dysfunction
  • Contraindications to pharyngeal wall augmentation treatment
  • Need for more intensive active cancer surveillance
  • Planned future surgical or medical treatments to the throat that would interfere with participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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Research Team

V

Vanesssa Torrecillas, MD

CONTACT

E

Elena Squire, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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