Clinical trial · Interventional
Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
Does the Use of Clinician Directed Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer Improve Swallowing Function Outcomes?
- 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)
Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and quality of life versus patient directed home exercises. The purpose of this prospective, interventional, pilot investigation is to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes and quality of life in the immediate and short-term basis compared to patients receiving standard of care patient directed independent home swallowing therapy. Patient compliance with home exercises programs is reportedly inconsistent. Patients may experience changes in their physical functioning and overall well-being that may impact their ability to follow-through with independent home therapy. Clinician directed swallowing therapy allows for ongoing assessment of changes that may warrant modifying the therapy program in terms of intensity of exercises and/or expectations. This facilitates individualizing the patient's therapy plan to maximize their function and ability to achieve goals. It is anticipated that individualizing swallowing therapy through weekly session will result in improved swallowing function.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinician-Directed Prophylactic Swallowing Exercises | Other | — | UNRESOLVED |
| Prophylactic Swallowing Home Exercise Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- G1 - Clinician-Directed Therapy
- description
- Clinician-Directed Weekly Swallowing Therapy: Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises and review the home swallowing exercise program. Each session will last 30 minutes +/- ten minutes. Other assessments include: * Clinician-Directed Prophylactic Swallowing Exercises * Prophylactic Swallowing Home Exercise Program * Penetration/Aspiration Scale (PAS) * Functional Oral Intake Scale (FOIS) * Eating Assessment Tool-10 (EAT-10) * University of Washington Quality of Life (UW-QOL) * Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) * DIGEST Safety Grade
- interventionNames
- Other: Prophylactic Swallowing Home Exercise Program
- Other: Clinician-Directed Prophylactic Swallowing Exercises
- type
- ACTIVE_COMPARATOR
- label
- G2 - Patient-Directed Home Therapy
- description
- Patient-Directed Home Swallowing Therapy: One face-to-face meeting with a study speech pathologist prior to initiation of treatment. During that session, they will be encouraged to practice the given exercises independently on a specific daily schedule regime throughout their treatment. Other assessments include: * Prophylactic Swallowing Home Exercise Program * Penetration/Aspiration Scale (PAS) * Functional Oral Intake Scale (FOIS) * Eating Assessment Tool-10 (EAT-10) * University of Washington Quality of Life (UW-QOL) * Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) * DIGEST Safety Grade
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV) related and non HPV related tonsil and base of tongue) 2. Scheduled to undergo definitive chemoradiation therapy 3. At least 18 years of age or older 4. Subject must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Surgical management in addition to chemoradiation therapy; 2. Cancer of the sinus, brain, or parotid; 3. Prior treatment for head and neck cancer; 4. Receiving chemoradiation treatment at an outside institution (i.e., non-University of Miami (UM) clinic); 5. Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer; 6. Prior neurologic disorder (i.e., Cerebrovascular accident (CVA), Traumatic brain injury (TBI), dementia) or current degenerative neuromuscular disease; 7. History of prior c-spine surgery; 8. History of prior vocal fold immobility
References
Publications (0)
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