EMST and Swallowing in Long-Term Survivors of HNCA

NCT03975465 | Terminated

• 1 other identifier: PRO32538
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Keywords

oropharyngeal cancer; laryngeal cancer; swallow; chemoradiation; expiratory muscle strength training; long-term survivor

Outcome Measures

Primary Outcomes (7)

• 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

• Maximum Expiratory Pressure (MEP) cm H20

  Change in maximum expiratory pressure level will be calculated from baseline to post-treatment.

  8 weeks

• 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

• 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

• 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

• 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

• 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

Other Outcomes (2)

• Eating Assessment Tool (EAT-10) (number)

  8 weeks

• M.D. Anderson Dysphagia Inventory (MDADI) (number)

  8 weeks

Study Arms (2)

Expiratory Muscle Strength Training

EXPERIMENTAL

Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions

Behavioral: Expiratory Muscle Strength Training

Pharyngeal Muscle Strengthening Exercises

ACTIVE COMPARATOR

Patients randomized to Standard Care will receive swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion

Behavioral: Pharyngeal Muscle Strengthening Exercises

Interventions

Expiratory Muscle Strength Training BEHAVIORAL

8 weeks of EMST at 75% maximum expiratory pressure (MEP)

Expiratory Muscle Strength Training

Pharyngeal Muscle Strengthening Exercises BEHAVIORAL

8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing

Pharyngeal Muscle Strengthening Exercises

Eligibility Criteria

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

You may qualify if:

• 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;
• 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;
• Ability to follow directions and engage in a program of rehabilitation

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• Froedtert Hospital: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (2)

University of Wisconsin Milwaukee

Milwaukee, Wisconsin, 53211, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders; Oropharyngeal Neoplasms; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Stomatognathic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Study Officials

• Barbara Pauloski, Ph.D.

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers assessing the outcomes will not know the arm to which the subject was randomized.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be randomized to an 8-week program of either Expiratory Muscle Strength Training (EMST) or Standard Care in order to examine the impact of EMST on swallowing function

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 5, 2019
• Study Start: September 10, 2018
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)