An interventional study of Pharyngeal Wall Augmentation Injection in Velopharyngeal Insufficiency, Head and Neck Cancer and Survivorship, sponsored by Vanessa Torrecillas. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Vanessa Torrecillas · Not applicable, Interventional, and Diagnostic
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.
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.
20 studies on the registry are indexed under Velopharyngeal Insufficiency; 9 are open to participants now.
This study's planned enrollment of 20 is close to the median of 20 across 13 interventional studies indexed under Velopharyngeal Insufficiency.
Browse Velopharyngeal Insufficiency studies →This is the only study on the registry with Vanessa Torrecillas as lead sponsor.
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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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction
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.
Time frame: Baseline Assessment
Accuracy of Nasometry for Identifying VPD
Proportion of participants with elevated nasalance scores (\>1 SD above normative mean) who also demonstrate VPD on flexible nasopharyngoscopy as determined by skilled rater.
Time frame: Baseline
Nasometry Characterization of Velopharyngeal Dysfunction
Nasalance will be quantified using nasometry (percent resonance score). Higher values indicate greater hypernasality.
Time frame: Baseline, 6 weeks post injection
Modified FEES Observation of Pharyngeal Residue and Nasal Regurgitation
Proportion of participants demonstrating residue or nasal regurgitation on modified FEES exam.
Time frame: Baseline, 6 weeks post injection
Patient-Reported Communication Function
Change in total Speech Handicap Index (SHI) score
Time frame: Baseline, 6 weeks post injection, 6 months post injection
Change in Patient Reported Swallowing-Related Quality of Life
SWAL-QOL total score
Time frame: Baseline, 6 months post injection, 6 months post injection
Plan to share: No — 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.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 9 months after the start.
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