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NCT01032928 · ClinicalTrials.gov registry record · Phase 2

Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer

A Phase 2 study, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT01032928: Completed Phase 2 study, sponsored by US Department of Veterans Affairs.

NCT01032928 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01032928, a Phase 2 study, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

Cancers of the head and neck require surgical, radiation, and chemotherapy treatments that are intended to cure the disease. These treatments have toxic effects on muscles and structures that are necessary to swallow safely and efficiently. The resulting swallowing problems (dysphagia) often remain chronic for Veterans and interfere with their ability to eat and drink. The cost burden to the VA health system is high. There is an urgent need to develop rehabilitative treatments that lessen these burdens. The proposed research is designed to test a novel swallowing therapy that includes the coordination of breathing with swallowing. Our study will train medically and surgically treated, chronically dysphagic Veterans with histories of oropharyngeal cancer in a novel therapy that involves both swallowing and respiratory systems. If the therapy is found to be effective, the long term goal of the project is to extend the study to a multi-site, clinical trial and test the longstanding effect of this treatment compared to other swallowing therapies on swallowing function, QOL and cost.

Primary Outcome

Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study. The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab. Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).

Interventions

  • BEHAVIORAL Respiratory-Swallow Phase training

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-06
Est. Completion 2013-09
Phase Phase 2
US Department of Veterans Affairs

632 total trials

What the finished NCT01032928 record still lists

NCT01032928 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Respiratory-Swallow Phase training is the first listed.

NCT01032928 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01032928 about?

NCT01032928 is a clinical study titled "Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer". Cancers of the head and neck require surgical, radiation, and chemotherapy treatments that are intended to cure the disease. These treatments have toxic effects on muscles and structures that are necessary to swallow safely and efficiently. The resulting swallowing problems (dysphagia) often remain ...

What is the current status of trial NCT01032928?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-06. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01032928?

The interventions under investigation include: Respiratory-Swallow Phase training (BEHAVIORAL).

Who is sponsoring clinical trial NCT01032928?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01032928's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 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 NCT01032928, the US trial registry maintained by the National Library of Medicine. NCT01032928 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.