Clinical trial · Interventional
Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
Injectable Augmentation Outcomes in Post-Radiation Head and Neck Cancer Patients With Velopharyngeal Dysfunction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Speech Disorder | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
| Velopharyngeal Insufficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pharyngeal Wall Augmentation Injection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic with Possible Injection Augmentation
- description
- 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.
- interventionNames
- Procedure: Pharyngeal Wall Augmentation Injection
Primary outcomes (1)
- measure
- Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction
- timeFrame
- Baseline Assessment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDYoussof 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
- BACKGROUNDStarmer 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
- BACKGROUNDNeubauer 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
- BACKGROUNDKummer, 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
- BACKGROUNDKarnell, 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
- BACKGROUNDKallambettu 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
- BACKGROUNDGolding-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
- BACKGROUNDAlfwaress 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.