Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study

NCT07264036 | Recruiting

• 1 other identifier: PJ05069
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Velopharyngeal Insufficiency; Survivorship; Dysphagia; Speech Disorder

Keywords

velopharyngeal dysfunction; hypernasal speech; pharyngeal wall augmentation; nasometry; head and neck cancer; survivorship

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline Assessment

Secondary Outcomes (5)

• Accuracy of Nasometry for Identifying VPD

  Baseline

• Nasometry Characterization of Velopharyngeal Dysfunction

  Baseline, 6 weeks post injection

• Modified FEES Observation of Pharyngeal Residue and Nasal Regurgitation

  Baseline, 6 weeks post injection

• Patient-Reported Communication Function

  Baseline, 6 weeks post injection, 6 months post injection

• Change in Patient Reported Swallowing-Related Quality of Life

  Baseline, 6 months post injection, 6 months post injection

Study Arms (1)

Diagnostic with Possible Injection Augmentation

EXPERIMENTAL

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

Interventions

Pharyngeal Wall Augmentation Injection PROCEDURE

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

Diagnostic with Possible Injection Augmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanessa Torrecillas: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (8)

• Youssof S, Romero-Clark C, Warner T, Plowman E. Dysphagia-related quality of life in oculopharyngeal muscular dystrophy: Psychometric properties of the SWAL-QOL instrument. Muscle Nerve. 2017 Jul;56(1):28-35. doi: 10.1002/mus.25441. Epub 2017 Feb 12.

  PMID: 27759888 BACKGROUND

• Starmer HM, Tippett DC, Webster KT. Effects of laryngeal cancer on voice and swallowing. Otolaryngol Clin North Am. 2008 Aug;41(4):793-818, vii. doi: 10.1016/j.otc.2008.01.018.

  PMID: 18570960 BACKGROUND

• Neubauer PD, Rademaker AW, Leder SB. The Yale Pharyngeal Residue Severity Rating Scale: An Anatomically Defined and Image-Based Tool. Dysphagia. 2015 Oct;30(5):521-8. doi: 10.1007/s00455-015-9631-4. Epub 2015 Jun 7.

  PMID: 26050238 BACKGROUND

• Kummer, A. W. (2014). Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 45(3), 183-195. https://doi.org/10.1044/2014_LSHSS-14-0036

  BACKGROUND

• Karnell, M. P., Christensen, A. J., & Rosenthal, E. L. (2007). Quality of life outcomes in head and neck cancer patients post-treatment. Otolaryngology-Head and Neck Surgery, 136(5), 698-703. https://doi.org/10.1016/j.otohns.2007.01.039

  BACKGROUND

• Kallambettu V, Bae Y, Carrau R. Velopharyngeal Function Post Head and Neck Cancer: A Review. Ear Nose Throat J. 2024 Sep;103(9):NP567-NP577. doi: 10.1177/01455613211070895. Epub 2022 Jan 28.

  PMID: 35081810 BACKGROUND

• Golding-Kushner KJ, Argamaso RV, Cotton RT, Grames LM, Henningsson G, Jones DL, Karnell MP, Klaiman PG, Lewin ML, Marsh JL, et al. Standardization for the reporting of nasopharyngoscopy and multiview videofluoroscopy: a report from an International Working Group. Cleft Palate J. 1990 Oct;27(4):337-47; discussion 347-8. doi: 10.1597/1545-1569(1990)0272.3.co;2.

  PMID: 2253379 BACKGROUND

• Alfwaress F, Kummer AW, Weinrich B. Nasalance Scores for Normal Speakers of American English Obtained by the Nasometer II Using the MacKay-Kummer SNAP-R Test. Cleft Palate Craniofac J. 2022 Jun;59(6):765-773. doi: 10.1177/10556656211025406. Epub 2021 Jun 29.

  PMID: 34184583 BACKGROUND

MeSH Terms

Conditions

Velopharyngeal Insufficiency; Head and Neck Neoplasms; Deglutition Disorders; Speech Disorders

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Diseases; Stomatognathic System Abnormalities; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vanessa Torrecillas, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanesssa Torrecillas, MD

CONTACT

434-924-2040; vge3bm@uvahealth.org

Elena Squire, MPH

CONTACT

434-243-3607; EM8KZ@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Otolaryngology - Head & Neck Surgery

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: March 24, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)