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NCT01279837 · ClinicalTrials.gov registry record · Phase 2

Pharyngocise Dose Response Study

A Phase 2 study, sponsored by University of Florida.

Completed
Registry status
Phase 2
Development phase
130
Enrollment target

NCT01279837: Completed Phase 2 study, sponsored by University of Florida.

NCT01279837 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01279837, a Phase 2 study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 2
Development phase
130 participants
Enrollment target

Study Summary

In this study supported by an American Cancer Society grant, the investigators are evaluating two levels of swallowing exercise intensity on the maintenance of swallowing muscles and their function in Head/Neck cancer patients undergoing radiotherapy. Patients in this study are randomly placed into different exercise groups and provided with exercises to perform daily during their radiation treatment. Their progress, diet management and swallowing ability are monitored throughout the treatment period and followed up until 3 months after radiation treatment. In addition to the daily treatment details, the patients perception of their swallowing ability and concerns about their health and treatment are also measured. This clinical trial will help to refine a previously investigated simple exercise package and provide a program of intervention that can help prevent medically related complications of swallowing difficulty (e.g. pneumonia, dehydration, prolonged tube feeding), and improve the ability to eat for patients with head / neck cancer. Ultimately it is hoped that this form of exercise therapy will help reduce the costs (personal and financial) to the patient, caregivers and community.

Primary Outcome

T2 Weighted Magnetic Resonance Imaging (MRI) to quantify baseline muscle parameters in the oral cavity and pharynx. The regions of interest will be identified on images using axial and coronal planes. Information regarding the muscle volume, composition (fat Vs muscle Vs edema) as reflected by the signal intensity.

Interventions

  • BEHAVIORAL Pharyngocise

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2006-06
Est. Completion 2011-12
Phase Phase 2
University of Florida

1,106 total trials

What the finished NCT01279837 record still lists

NCT01279837 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Pharyngocise is the first listed.

NCT01279837 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01279837 about?

NCT01279837 is a clinical study titled "Pharyngocise Dose Response Study". In this study supported by an American Cancer Society grant, the investigators are evaluating two levels of swallowing exercise intensity on the maintenance of swallowing muscles and their function in Head/Neck cancer patients undergoing radiotherapy. Patients in this study are randomly placed into ...

What is the current status of trial NCT01279837?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2006-06. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01279837?

The interventions under investigation include: Pharyngocise (BEHAVIORAL).

Who is sponsoring clinical trial NCT01279837?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01279837's enrollment target sits among peer trials

130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01279837, the US trial registry maintained by the National Library of Medicine. NCT01279837 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.