Status:
COMPLETED
Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
Lead Sponsor:
University of Miami
Conditions:
Head and Neck Cancer
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ver...
Detailed Description
This is a single-site, two-arm, 1:1 randomized, prospective, interventional, pilot study to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03435471
Start Date
September 17 2018
End Date
January 13 2021
Last Update
January 27 2021
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136