CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Respiratory-Swallow Phase trainingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01032928
NCT01032928Phase 2Completed

Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer

US Department of Veterans Affairs·interventional·Posted Dec 16, 2009·Updated Jan 1, 2015

In Brief

A Phase 2 clinical trial evaluating Respiratory-Swallow Phase training for Oropharyngeal Dysphagia and Oropharyngeal Cancer. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2009
Enrollment StartJun 1, 2011
Primary CompletionJul 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.5 years ago

Interventions

Respiratory-Swallow Phase trainingbehavioral

Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.