Malignant Head and Neck Neoplasm
Conditions
Brief 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.
Interventions
OTHERBest Practice
Undergo therapy session conducted by a speech pathologist
OTHEREducational Intervention
Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus
OTHERExercise Intervention
Perform prescribed home exercises
Participate in EMST
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a definitive, curative treatment plan consisting of chemoradiation for head & neck cancer * Surgery, if required, must be limited to: diagnostic biopsy
Exclusion criteria
* Participants enrolled in a radiation de-intensification protocol * Current or previous neurological disease, which may adversely affect swallowing * History of oropharyngeal swallowing disorder prior to cancer diagnosis * Previous neurosurgery on the brain * Severe chronic obstructive pulmonary disease (COPD) requiring oxygen dependence, as this is a contraindication of EMST
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway safety during swallowing assessed using the Penetration-Aspiration Scale | Up to 1 year | Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expiratory flow assessed using portable digital peak flow meter | Up to 1 year | Exploratory mixed effect model will be used to investigate respiratory measures with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. |
| Functional Oral Intake Scale (FOIS) | Up to 1 year | Collected variables will be estimated through patient and clinician surveys. |
| Lingual strength defined as the maximum pressure of the tongue pressing against the hard palate measured using the Iowa Oral Performance Instrument | Up to 1 year | Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. |
| Maximum expiratory pressure assessed using the MicroRPM pressure meter | Up to 1 year | Exploratory mixed effect model will be used to investigate respiratory measures with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. |
| Eating Assessment Tool-10 | Up to 1 year | Collected variables will be estimated through patient and clinician surveys. |
| Patient reported quality of life assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire | Up to 1 year | Exploratory mixed effect model will be used to investigate quality of life with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. |
| Respiratory-swallow phase patterns captured using the standard Modified Barium Swallow Study | Up to 1 year | Logistic regression method will be used to explore associations between treatment and respiratory-swallow phase (normal/abnormal). |
| Swallow pathophysiology assessed using the Modified Barium Swallow Impairment Profile | Up to 1 year | Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. |
| Maximum mandibular opening using the TheraBite range of motion scale | Up to 1 year | Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. |
Countries
United States
Outcome results
None listed