Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study

April 27, 2026 updated by: Vanessa Torrecillas

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Velopharyngeal dysfunction (VPD) is a disorder in which the soft palate and posterior pharyngeal wall do not close adequately during speech and swallowing. Head and neck cancer (HNC) survivors may develop VPD as a result of neuromuscular impairment from surgical resection and/or radiation therapy. Consequences include hypernasal speech from nasal air escape, nasopharyngeal residue during swallowing, nasal regurgitation, and reductions in speech and swallowing-related quality of life. Despite its clinical relevance, VPD in HNC survivors is under-recognized, and evidence regarding optimal diagnostic methods and effective interventions remains limited. This study aims to characterize VPD in this population, evaluate the diagnostic utility of advanced assessment tools, and assess the therapeutic effect of pharyngeal wall augmentation.

Overview This is a prospective study using a multidisciplinary, multimodal assessment protocol to evaluate speech and swallowing function in HNC survivors with suspected or confirmed VPD. Participants will undergo standardized clinical, instrumental, and patient-reported outcome assessments. A subset of participants with confirmed VPD will receive pharyngeal wall augmentation as part of standard clinical care, allowing for pre- and post-intervention comparison.

Aim 1: Characterization of VPD in HNC Survivors

Describe the prevalence, severity, and functional impact of VPD in this population. Participants will complete a comprehensive evaluation including:

Oropharyngeal physical examination to identify structural or neuromuscular contributors to impaired velopharyngeal closure.

Flexible nasolaryngoscopy to assess closure patterns during speech and swallowing tasks.

Acoustic speech analysis and objective measures of speech intelligibility.

Nasometry to quantify nasalance and the degree of hypernasality.

Clinical swallowing evaluation, documenting perceptual indicators of safety and efficiency.

Fiberoptic Endoscopic Evaluation of Swallowing (FEES) to visualize bolus flow, pharyngeal residue, and nasal regurgitation.

Patient-reported outcomes will include the Speech Handicap Index (SHI) and the Swallowing Quality of Life Questionnaire (SWAL-QOL). These measures will characterize functional limitations associated with VPD.

Aim 2: Feasibility and Utility of Advanced Diagnostic Tools Aim 2a: Nasometry as a Diagnostic Indicator This component evaluates whether nasalance scores can reliably identify VPD. The primary hypothesis is that nasalance values >1 standard deviation above normative means will demonstrate a positive predictive value ≥75% when compared with endoscopic confirmation. Correlations will be assessed between nasalance and SHI scores to determine whether acoustic measures reflect patient-perceived communication limitations.

Aim 2b: FEES Indicators of VPD and Functional Correlates

This component assesses whether swallowing abnormalities on FEES are associated with VPD. Participants with confirmed VPD are expected to exhibit:

increased pharyngeal residue, and/or nasal regurgitation during bolus presentation.

These findings will be correlated with SWAL-QOL scores to determine whether FEES characteristics reflect functional swallowing impairment. Results may support FEES as a useful adjunctive tool in evaluating the impact of VPD on swallowing physiology.

Aim 3: Efficacy of Pharyngeal Wall Augmentation Participants with confirmed VPD who are clinically indicated for treatment will undergo pharyngeal wall augmentation using standard-of-care techniques. Injection material and volume will be determined by treating clinicians. The intervention is intended to reduce the velopharyngeal gap and improve closure during speech and swallowing.

Outcome Measures

Pre- and post-intervention comparisons will include:

Nasalance scores Acoustic speech parameters and overall intelligibility Perceptual ratings of speech resonance FEES findings (pharyngeal residue, nasal regurgitation) Patient-reported outcomes (SHI, SWAL-QOL) Participant-reported impressions of change

The primary hypothesis is that pharyngeal wall augmentation will result in measurable improvement in both objective assessments and patient-reported function.

Significance

This study will provide:

A comprehensive description of VPD in HNC survivors. Evidence on the diagnostic value of nasometry and FEES for identifying clinically meaningful VPD.

Prospective data on the functional impact of pharyngeal wall augmentation. Findings will inform best practices for the diagnosis and management of VPD in HNC survivors and support the development of multidisciplinary clinical pathways for improving communication and swallowing outcomes.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vanessa Torrecillas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic with Possible Injection Augmentation
All participants will undergo a standardized, multidisciplinary evaluation including physical examination, flexible nasolaryngoscopy, acoustic speech analysis, nasometry, clinical swallowing assessment, and fiberoptic endoscopic evaluation of swallowing (FEES). A subset of participants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection as part of standard-of-care treatment. All participants, regardless of whether they receive the injection, will have pre-assessment data collected to evaluate speech intelligibility, nasalance, swallowing function, and patient-reported outcomes. The patients who undergo the pharyngeal augmentation injection will also have post-assessment data collected. No formal comparison between participants who do and do not receive the injection will be performed; all data will be analyzed individually.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction
Time Frame: Baseline Assessment
Feasibility will be reported as the percentage of enrolled participants with complete, usable nasometry and FEES data at baseline. Data quality will be defined by the proportion of recordings meeting predefined technical standards for interpretation. Additional exploratory analyses will examine correlations between nasometry and FEES findings and clinical reference standards (perceptual speech ratings, SHI and SWAL-QOL scores), but correlation statistics will not be used as outcome units for feasibility reporting.
Baseline Assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Nasometry for Identifying VPD
Time Frame: Baseline
Proportion of participants with elevated nasalance scores (>1 SD above normative mean) who also demonstrate VPD on flexible nasopharyngoscopy as determined by skilled rater.
Baseline
Nasometry Characterization of Velopharyngeal Dysfunction
Time Frame: Baseline, 6 weeks post injection
Nasalance will be quantified using nasometry (percent resonance score). Higher values indicate greater hypernasality.
Baseline, 6 weeks post injection
Modified FEES Observation of Pharyngeal Residue and Nasal Regurgitation
Time Frame: Baseline, 6 weeks post injection
Proportion of participants demonstrating residue or nasal regurgitation on modified FEES exam.
Baseline, 6 weeks post injection
Patient-Reported Communication Function
Time Frame: Baseline, 6 weeks post injection, 6 months post injection
Change in total Speech Handicap Index (SHI) score
Baseline, 6 weeks post injection, 6 months post injection
Change in Patient Reported Swallowing-Related Quality of Life
Time Frame: Baseline, 6 months post injection, 6 months post injection
SWAL-QOL total score
Baseline, 6 months post injection, 6 months post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanessa Torrecillas

Investigators

  • Principal Investigator: Vanessa Torrecillas, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJ05069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study results will be published in peer-reviewed journals. Individual participant-level data will not be made publicly available. Only aggregate data and summary findings will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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