Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
Head and Neck Cancer, Oropharynx Cancer
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Prophylactic Swallowing Therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV) related and non HPV related tonsil and base of tongue)
- Scheduled to undergo definitive chemoradiation therapy
- At least 18 years of age or older
- Subject must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Surgical management in addition to chemoradiation therapy;
- Cancer of the sinus, brain, or parotid;
- Prior treatment for head and neck cancer;
- Receiving chemoradiation treatment at an outside institution (i.e., non-University of Miami (UM) clinic);
- Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer;
- Prior neurologic disorder (i.e., Cerebrovascular accident (CVA), Traumatic brain injury (TBI), dementia) or current degenerative neuromuscular disease;
- History of prior c-spine surgery;
- History of prior vocal fold immobility
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
G1 - Clinician-Directed Therapy
G2 - Patient-Directed Home Therapy
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
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