MedTrace Logo

Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study

NCT07264036 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Pharyngeal Wall Augmentation Injection

Participants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection. The procedure involves the submucosal injection of a biocompatible material into the posterior pharyngeal wall to improve velopharyngeal closure during speech and swallowing. Injection volume and technique will be determined by the treating clinician based on individual anatomy and functional assessment. All participants will undergo standardized assessments of speech intelligibility, nasalance, swallowing function, and patient-reported outcomes before and after the procedure. Timing: The procedure will occur once at the clinically indicated visit. Post-procedure assessments will be conducted at standardized follow-up intervals to evaluate functional outcomes

Sponsors & Collaborators

  • Vanessa Torrecillas

    lead OTHER

Principal Investigators

  • Vanessa Torrecillas, MD · University of Virginia

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-24
Primary Completion
2027-01-01
Completion
2027-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264036 on ClinicalTrials.gov