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EMST and Swallowing in Long-Term Survivors of HNCA

NCT ID: NCT03975465

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2024-06-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Neoplasms Deglutition Disorders

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Researchers assessing the outcomes will not know the arm to which the subject was randomized.

Study Groups

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Expiratory Muscle Strength Training

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

Group Type EXPERIMENTAL

Expiratory Muscle Strength Training

Intervention Type BEHAVIORAL

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

Pharyngeal Muscle Strengthening Exercises

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

Group Type ACTIVE_COMPARATOR

Pharyngeal Muscle Strengthening Exercises

Intervention Type BEHAVIORAL

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

Interventions

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Expiratory Muscle Strength Training

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

Intervention Type BEHAVIORAL

Pharyngeal Muscle Strengthening Exercises

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Froedtert Hospital

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role lead

Responsible Party

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Barbara Pauloski

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Pauloski, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Milwaukee

Locations

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University of Wisconsin Milwaukee

Milwaukee, Wisconsin, United States

Site Status

Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PRO32538

Identifier Type: -

Identifier Source: org_study_id