Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer
Condition: Malignant Head and Neck Neoplasm
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      This randomized clinical trial studies how well expiratory muscle strength training works in
      improving bulbar function and quality of life in patients with head and neck cancer.
      Expiratory muscle strength training may help to strengthen the muscles involved in breathing
      and swallowing and may allow improved breathing, airway safety, swallow function, and quality
      of life in patients with head and neck cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Investigate the impact of a prophylactic targeted exercise program, expiratory muscle
      strength training (EMST), on swallowing function and well-being of individuals on head and
      neck cancer (HNC).

      II. Determine the impact of EMST on objective respiratory measures of individuals with HNC.

      III. Determine the relationship between mean dose across the swallowing muscles (oral tongue
      and supra-hyoids, base of tongue, superior, middle and inferior pharyngeal constrictors,
      proximal esophagus)/dose on each muscle and the swallowing functional outcomes from aim 1.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive standard of care comprising of written patient education materials
      focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients
      participate in a therapy session conducted by a speech pathologist over 30 minutes once per
      week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at
      home daily for 3 sets of 10 repetitions.

      ARM II: Patients receive standard of care comprising of written patient education materials
      focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients
      participate in a therapy session conducted by a speech pathologist over 30 minutes once per
      week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home
      daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30
      minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during
      chemoradiation therapy.

      After completion of study, patients are followed up at 1, 3, 6, and 12 months.
    

Intervention name(s): Best Practice; Educational Intervention; Exercise Intervention; Expiratory Muscle Strength Training; Quality-of-Life Assessment; Questionnaire Administration
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Undergo therapy session conducted by a speech pathologist; Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus; Perform prescribed home exercises; Participate in EMST; Ancillary studies; Ancillary studies
Other intervention name(s): standard of care; standard therapy; Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; EMST; Quality of Life Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care