EMST and Swallowing in Long-Term Survivors of HNCA

Head and Neck Neoplasms Clinical Trial

Official title:

Effects of Expiratory Muscle Strength Training (EMST) on Long-Term Swallowing Dysfunction in Persons With Head and Neck Cancer (HNCA) Post Irradiation (RT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03975465
• Other study ID #: PRO32538
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: October 1, 2025

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Milwaukee
• Contact: Barbara Pauloski, Ph.D.
• Phone: 4142296719
• Email: pauloski[@]uwm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously.

Description:

Twenty (20) persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously will be randomized to an 8-week program of either EMST only and Standard Care only in order to examine the impact of EMST on swallowing function. The EMST program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks at 75% of maximum expiratory strength. Patients randomized to the EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Standard Care will include swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion. Subjects will be instructed to practice these exercises following a progressive protocol 5 days per week for 8 weeks.

All subjects will be evaluated at baseline and at the completion of their rehabilitation program. Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, administration of swallow-related quality of life (QOL) questionnaires, and documentation of current diet using the International Dysphagia Diet Standardisation Initiative (IDDSI) Drink Levels and Food Levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject was treated for cancer in the oral cavity, oropharynx, hypopharynx, larynx, or for an unknown primary at least 5 years prior to enrollment. Subjects may have had surgery as long as a minimum dose of 50 Gy of radiation was part of the treatment;

2. Subject must have a current swallow complaint or impairment; these include but are not limited to reduced oral intake, perceived difficulty with bolus transport (e.g. feeling of food sticking in throat); aspiration on various bolus consistencies;

3. Ability to follow directions and engage in a program of rehabilitation

Exclusion Criteria:

1. the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke);

2. the subject presents with contraindications for EMST as specified in the EMST150 package insert unless cleared for participation by the subject's physician. These conditions include untreated hypertension, untreated gastroesophageal reflux diseas, recent stroke, lung disease, and pregnancy.

Related Conditions & MeSH terms

• Deglutition Disorders
• Head and Neck Neoplasms

Intervention

Behavioral:
• Expiratory Muscle Strength Training
8 weeks of EMST at 75% maximum expiratory pressure (MEP)
• Pharyngeal Muscle Strengthening Exercises
8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	University of Wisconsin Milwaukee	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee	Froedtert Hospital, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eating Assessment Tool (EAT-10) (number)	Change in score on the EAT-10 will be calculated from baseline to mid-treatment to post-treatment. EAT-10 is an ordinal rating scale with values that range from 0 to 40, with lower score reflecting better function.	8 weeks
Other	M.D. Anderson Dysphagia Inventory (MDADI) (number)	Change in scores on the M.D. Anderson Dysphagia Inventory (MDADI) will be calculated from baseline to post-treatment. MDADI consists of four ordinal rating scales with scores ranging from 0 to 100 with higher score reflecting better function.	8 weeks
Primary	Level of Oral Intake (number)	Change in Food Level and Drink Level on International Dysphagia Diet Standardisation Initiative (IDDSI) scale will be calculated from baseline to post-treatment.; IDDSI scale rates the level of liquid or food that the person can eat. Scale values range from 0 to 7, with higher values indicating better outcome (greater ability to eat).	8 weeks
Primary	Maximum Expiratory Pressure (MEP) cm H20	Change in maximum expiratory pressure level will be calculated from baseline to post-treatment.	8 weeks
Primary	Extent of hyoid movement (mm)	From Videofluoroscopic Swallow Studies (VFSS), the change in extent of hyoid movement in mm will be determined from baseline to post-treatment.	8 weeks
Primary	Upper esophageal sphincter (UES) opening width (mm)	From Videofluoroscopic Swallow Studies (VFSS), the change in width of UES opening width in mm will be determined from baseline to post-treatment.	8 weeks
Primary	Presence of pharyngeal residue (dichotomous)	From Videofluoroscopic Swallow Studies (VFSS), the presence of residue in the pharynx (yes or no) will be determined from baseline to post-treatment.	8 weeks
Primary	Penetration-Aspiration Scale rating (number)	From Videofluoroscopic Swallow Studies (VFSS), change in the Penetration-Aspiration Scale (PAS) score will be determined from baseline to post-treatment. Penetration-Aspiration Scale is an 8-point ordinal rating scale that rates the depth to which food or liquid invades the airway. Values range from a minimum of 1 to a maximum of 8; higher values represent worse outcome (i.e. greater depth of invasion into the airway)	8 weeks
Primary	Timing of Aspiration (category)	From Videofluoroscopic Swallow Studies (VFSS), timing of aspiration will be determined from baseline to post-treatment. Timing is identified as a category, either before, during, or after.	8 weeks