Clinical trial NCT03175289: Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer
Official title: The Impact of Expiratory Muscle Strength Training on Bulbar Function and Well Being of Individuals With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Head and Neck Neoplasm
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 49
Sex: ALL
Minimum age (years): 19
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Airway safety during swallowing assessed using the Penetration-Aspiration Scale
timeFrame: Up to 1 year
Secondary outcomes:
measure: Eating Assessment Tool-10
timeFrame: Up to 1 year
measure: Expiratory flow assessed using portable digital peak flow meter
timeFrame: Up to 1 year
measure: Functional Oral Intake Scale (FOIS)
timeFrame: Up to 1 year
measure: Lingual strength defined as the maximum pressure of the tongue pressing against the hard palate measured using the Iowa Oral Performance Instrument
timeFrame: Up to 1 year
measure: Maximum expiratory pressure assessed using the MicroRPM pressure meter
timeFrame: Up to 1 year
measure: Maximum mandibular opening using the TheraBite range of motion scale
timeFrame: Up to 1 year
measure: Patient reported quality of life assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: Up to 1 year
measure: Respiratory-swallow phase patterns captured using the standard Modified Barium Swallow Study
timeFrame: Up to 1 year
measure: Swallow pathophysiology assessed using the Modified Barium Swallow Impairment Profile
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Loni Arrese, PhD, SLP
role: PRINCIPAL_INVESTIGATOR
References: