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

NCT03175289 | Completed DMC

• 2 other identifiers: OSU-16023NCI-2017-00848
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Head and Neck Neoplasm

Outcome Measures

Primary Outcomes (1)

• Airway safety during swallowing assessed using the Penetration-Aspiration Scale

  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.

  Up to 1 year

Secondary Outcomes (9)

• Eating Assessment Tool-10

  Up to 1 year

• Expiratory flow assessed using portable digital peak flow meter

  Up to 1 year

• Functional Oral Intake Scale (FOIS)

  Up to 1 year

• 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

• Maximum expiratory pressure assessed using the MicroRPM pressure meter

  Up to 1 year

Study Arms (2)

Arm I (standard of care, home exercises)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Educational Intervention; Other: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

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

EXPERIMENTAL

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

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

Interventions

Best Practice OTHER

Undergo therapy session conducted by a speech pathologist

Also known as: standard of care, standard therapy

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

Educational Intervention OTHER

Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

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

Exercise Intervention OTHER

Perform prescribed home exercises

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

Expiratory Muscle Strength Training OTHER

Participate in EMST

Also known as: EMST

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

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

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

Questionnaire Administration OTHER

Ancillary studies

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

Eligibility Criteria

• Age: 19 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a definitive, curative treatment plan consisting of chemoradiation for head \& neck cancer
• Surgery, if required, must be limited to: diagnostic biopsy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Loni Arrese, PhD, SLP

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: September 29, 2016
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (1)