Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer

Completed · Not applicable

Conditions studied: Head and Neck Cancer, Oropharynx Cancer

In brief

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.

Key facts

Study ID

NCT03435471

Run by

University of Miami

People needed

30

Starts

2018-09-17

Expected to finish

2021-01-13

Last updated by the study team

2021-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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