Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer
Condition: Oropharyngeal Dysphagia; Oropharyngeal Cancer
MeSH terms: Oropharyngeal Neoplasms; Deglutition Disorders
Intervention: Respiratory-Swallow Phase training
Intervention description: Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Swallowing; Dysphagia; Breathing and swallowing; Oropharyngeal cancer

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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