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NCT07264036Recruiting

Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study

Injectable Augmentation Outcomes in Post-Radiation Head and Neck Cancer Patients With Velopharyngeal Dysfunction

Source: ClinicalTrials.gov · Last updated 28 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
17 Nov 2025
Start date
24 Mar 2026
Primary completion date
1 Jan 2027
Lead sponsor
Vanessa Torrecillas
NCT number
NCT07264036

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 24 Mar 2026 to the primary completion date, 1 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Who the study is looking for

  • English-speaking adults (≥18 years) History of head and neck cancer treated with surgical resection, chemoradiation, or both Presence of perceptual hypernasality on clinical assessment

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Virginia
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.