NCT03435471

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?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 when compared to patient-directed home-based swallowing therapy. The investigators anticipate at least 40 subjects will need to be enrolled/consented in order to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30 participants. All subjects in each group will receive a face-to-face education session with a speech pathologist to review a recommended program of swallowing exercises prior to initiation of chemoradiation at their baseline (pre-treatment evaluation session).

Conditions

• Head and Neck Cancer
• Oropharynx Cancer

Interventions

Type	Name	Description
OTHER	Prophylactic Swallowing Home Exercise Program	The home exercise program will consist of six exercises that are recommended to be practiced three times per day. Subjects will complete a weekly exercise log to track compliance.
OTHER	Clinician-Directed Prophylactic Swallowing Exercises	Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises

Timeline

• Start date: 2018-09-17
• Primary completion: 2020-07-17
• Completion: 2021-01-13
• First posted: 2018-02-19
• Last updated: 2021-01-27

Locations

1 site across 1 country: United States