Pharyngocise Dose Response Study
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      In an earlier pilot study, a regime of simple swallowing exercises was identified as useful
      in maintaining oropharyngeal muscle characteristics as measured by T2 weighted Magnetic
      Resonance Imaging (MRI) and produced a trend toward improved function for swallowing in
      patients undergoing radiotherapy for head and neck cancer. The purpose of this current study
      is to evaluate the dose response of two levels of swallowing exercise intensity on the
      maintenance of muscle composition and function for swallowing in Head/Neck cancer patients
      undergoing radiotherapy.

      HYPOTHESIS: A program of intensive swallowing exercise (Pharyngocise) will maintain muscle
      function in the oral cavity and pharynx during radiotherapy, preserving or supporting
      swallowing function in Head/Neck cancer patients.

      STUDY DESIGN: 130 patients with Head/Neck cancer, confirmed by clinical history and exam,
      will be recruited over a 4 year period. All subjects will undergo an initial baseline work
      up, including a standardized clinical and instrumental swallowing evaluation, psychosocial
      scales, nutritional exam, and T2 weighted MRI prior to the first radiation therapy. Subjects
      will be randomized into 1 of 3 groups:

      Group A: Usual care (control) group - patients will receive swallowing and prescribed dietary
      intervention during the radiotherapy period prescribed by the attending physician.

      Group B: High intensity pharyngocise treatment group - patients will receive twice daily
      swallowing intervention by a speech language pathologist, consisting of the battery of
      isometric/isotonic exercises.

      Group C: Low intensity pharyngocise treatment group - patients will receive a single
      instructional exercise session on the isometric/isotonic exercises from a Speech Language
      Pathologist and a practice tape to support home practice of the exercises.

      All patients will be treated for approximately 6 weeks and followed for 3 months post
      treatment. Baseline assessments will be repeated. In addition, daily treatment details,
      patients perception of current swallowing ability and progress in therapy will be recorded by
      the Speech Pathologist. Participants will be independently monitored throughout the treatment
      period by researcher blind to the treatment group assigned, via weekly phone interview
      sessions. Compliance with the treatment techniques, and the occurrence of any negative
      endpoints such as occurrence of aspiration pneumonia will be recorded.
    

Intervention name(s): Pharyngocise
Intervention type(s): Behavioral
Intervention description(s): swallowing intervention by a speech language pathologist, consisting of the battery of isometric / isotonic exercises
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: swallowing disorders; swallowing therapy; head neck cancer; oropharyngeal dysphagia