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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 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.

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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.

Interventions

  • OTHER Prophylactic Swallowing Home Exercise Program
  • OTHER Clinician-Directed Prophylactic Swallowing Exercises

Study Locations (1)

Florida

  • University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2018-09-17
Est. Completion 2021-01-13
Phase NA

Sponsor

University of Miami

721 total trials

What the Registry Record Tells You About NCT03435471

The ClinicalTrials.gov registry entry for NCT03435471 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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