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NCT03435471 · ClinicalTrials.gov registry record · NA
Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
A NA study of Head and Neck Cancer and Oropharynx Cancer, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03435471: Completed NA study of Head and Neck Cancer and Oropharynx Cancer, sponsored by University of Miami.
NCT03435471 is a NA study of Head and Neck Cancer and Oropharynx Cancer that has completed, run by University of Miami. The registered enrollment target is 30 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03435471, a NA study of Head and Neck Cancer and Oropharynx Cancer, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Swallowing status will be measured using Functional Oral Intake Scale (FOIS). FOIS has a range from 0 (most restrictive) to 7 (least restrictive).
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 |
What the finished NCT03435471 record still lists
NCT03435471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower).
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.
NCT03435471 reports a single indexed study location in Florida.
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.
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).
Who is sponsoring clinical trial NCT03435471?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03435471's enrollment target sits among peer trials
30 174th of 250 higher than 66 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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