Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer

Completed · Phase 2

Conditions studied: Oropharyngeal Dysphagia, Oropharyngeal Cancer

In brief

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.

Key facts

Study ID

NCT01032928

Run by

US Department of Veterans Affairs

People needed

30

Starts

2011-06-01

Expected to finish

2013-09-01

Last updated by the study team

2015-01-01

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• at least 21 years of age
• agreed to participate in this study and signed an informed consent, either completed by the participant or designated other
• have chronic impairments in oropharyngeal swallowing function following chemotherapy, radiation, and/or surgical intervention for the treatment of first time diagnosis of squamous cell carcinoma of the head and neck
• have completed medical treatments for his/her cancer and any traditional swallowing therapy at least 6 months earlier
• pass a cognitive screening (COGNISTAT)
• have at least one area of impairment (initiation of pharyngeal swallow, anterior hyolaryngeal excursion, extent and duration of PES opening, tongue base retraction, pharyngeal residue) as indicated by the results of the pre-intervention MBSImP (total sum MBSImP
• have PAS scores >/= 3 on 10% of swallows on pre-intervention MBSS
• have a non-optimal (E-I, I-E, or I-I) breathing pattern on 60% of trial swallows.

You may not qualify if…

• known allergy or dietary restriction for food or contrast materials used during the exam
• evidence of persistent or recurrent disease on physical examination of the head and neck
• evidence of esophageal stricture noted on MBS
• recurrent oropharyngeal cancer and/or are being treated for other cancer(s) concurrently
• severe COPD (see Pulmonary Criteria below)
• nasogastric feeding tube
• recent change in swallowing status characterized by increase in perceived or observed -swallowing problems by patient, family or testing SLP
• any co-occurring neurological impairment affecting muscle strength and/or cognition
• history of aspiration pneumonia over the past 12 months.
• fail cognitive screening
• absence of swallowing impairment
• evidence of esophageal stricture on MBS
• inability to tolerate at least one of the liquid barium consistencies
• consistent optimal respiratory-swallow phase patterning

Where it is running

• Ralph H Johnson VA Medical Center, Charleston — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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