Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 40
Summary
- Conditions
- Head and Neck Cancer
- Oropharynx Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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).
Tracking Information
- NCT #
- NCT03435471
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Donna S Lundy, PhD University of Miami
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