Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer

The Ohio State University

Status: Completed

Conditions: Malignant Head and Neck Neoplasm

Treatments: Other: Quality-of-Life Assessment; Other: Educational Intervention; Other: Best Practice; Other: Questionnaire Administration; Other: Expiratory Muscle Strength Training; Other: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03175289

OSU-16023

NCI-2017-00848 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 19 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Arm I (standard of care, home exercises)

Active Comparator group

Description:

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.

Treatment:

Other: Best Practice

Other: Exercise Intervention

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Educational Intervention

Arm II (standard of care, home exercises, EMST)

Experimental group

Description:

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

Treatment:

Other: Expiratory Muscle Strength Training

Other: Best Practice

Other: Exercise Intervention

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Educational Intervention