NCT07264036 Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
| NCT ID | NCT07264036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanessa Torrecillas |
| Condition | Velopharyngeal Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-03-24 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Vanessa Torrecillas, MD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT07264036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Velopharyngeal Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07264036 currently recruiting?
Yes, NCT07264036 is actively recruiting participants. Contact the research team at vge3bm@uvahealth.org for enrollment information.
Where is the NCT07264036 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT07264036 clinical trial?
NCT07264036 is sponsored by Vanessa Torrecillas. The principal investigator is Vanessa Torrecillas, MD at University of Virginia. The trial plans to enroll 20 participants.