Improving nasal-sounding speech and swallowing in head and neck cancer survivors with velopharyngeal dysfunction
Injectable Augmentation Outcomes in Post-Radiation Head and Neck Cancer Patients With Velopharyngeal Dysfunction
NA · University of Virginia · NCT07264036
This pilot effort tests whether injecting material to 'plump' the back wall of the throat (pharyngeal wall augmentation) can help head and neck cancer survivors with velopharyngeal dysfunction speak less nasally and swallow better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT07264036 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-site pilot that uses multidisciplinary, multimodal assessments to characterize velopharyngeal dysfunction (VPD) in head and neck cancer survivors. Participants undergo physical exam, flexible nasolaryngoscopy, speech recordings and acoustic analysis, nasometry, clinical swallowing evaluation, and fiberoptic endoscopic evaluation of swallowing (FEES). A subset with confirmed VPD will receive pharyngeal wall augmentation as part of routine clinical care, with pre- and post-intervention comparisons of speech, swallowing, and patient-reported outcomes. The study also aims to determine prevalence and to test the diagnostic usefulness of advanced measures like nasometry in this population.
Who should consider this trial
Good fit: English-speaking adults (age 18+) who are head and neck cancer survivors with perceptual hypernasality and no suspected non-cancer causes of velopharyngeal dysfunction and who have no contraindication to augmentation are ideal candidates.
Not a fit: Patients with non–cancer-related VPD, those requiring more intensive active cancer surveillance, or those with planned future pharyngeal surgeries or anatomical problems not addressed by augmentation are unlikely to benefit from this intervention in the study.
Why it matters
Potential benefit: If successful, pharyngeal wall augmentation could reduce hypernasal speech, lower nasal regurgitation during swallowing, and improve speech- and swallowing-related quality of life for affected survivors.
How similar studies have performed: Augmentation approaches have shown benefit in small series and in non-cancer VPD populations, but data specifically in head and neck cancer survivors are limited, making this application relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Vanessa Torrecillas, MD — University of Virginia
- Study coordinator: Vanesssa Torrecillas, MD
- Email: vge3bm@uvahealth.org
- Phone: 434-924-2040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Velopharyngeal Insufficiency, Head and Neck Cancer, Survivorship, Dysphagia, Speech Disorder, velopharyngeal dysfunction, hypernasal speech, pharyngeal wall augmentation