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Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
NCT03435471 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Prophylactic Swallowing Home Exercise Program
- OTHER Clinician-Directed Prophylactic Swallowing Exercises
Study Locations (1)
Florida
- University of Miami — Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2021-01-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03435471
The ClinicalTrials.gov registry entry for NCT03435471 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 667 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions — of which Prophylactic Swallowing Home Exercise Program is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03435471 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03435471 about?
NCT03435471 is a clinical study titled "Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer". 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 investi...
What is the current status of trial NCT03435471?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2018-09-17. Estimated completion is 2021-01-13.
What conditions does trial NCT03435471 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Oropharynx Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03435471?
The interventions under investigation include: Prophylactic Swallowing Home Exercise Program (OTHER), Clinician-Directed Prophylactic Swallowing Exercises (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03435471?
This trial is sponsored by University of Miami, which has 667 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03435471 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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