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Swallowing Muscle Training for Head and Neck Cancer Survivors

N/A
Recruiting
Led By Barbara Pauloski, Ph.D.
Research Sponsored by University of Wisconsin, Milwaukee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether training the muscles used for swallowing can help people who've had radiation therapy for head and neck cancer, 5+ years ago.

Who is the study for?
This trial is for long-term survivors of head and neck cancer who were treated with radiation or chemoradiotherapy at least 5 years ago. Participants must have swallowing difficulties related to their cancer treatment, be able to follow directions, and engage in rehabilitation exercises.
What is being tested?
The study tests whether expiratory muscle strength training (EMST) improves swallowing function, oral intake, and quality of life related to swallowing in individuals who've had head and neck cancer treatments.
What are the potential side effects?
Potential side effects are not detailed but may include discomfort from the exercises or exacerbation of existing conditions like untreated hypertension or gastroesophageal reflux if participants haven't been cleared by a physician.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Extent of hyoid movement (mm)
Level of Oral Intake (number)
Maximum Expiratory Pressure (MEP) cm H20
+4 more
Other study objectives
Eating Assessment Tool (EAT-10) (number)
M.D. Anderson Dysphagia Inventory (MDADI) (number)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Expiratory Muscle Strength TrainingExperimental Treatment1 Intervention
Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions
Group II: Pharyngeal Muscle Strengthening ExercisesActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Expiratory Muscle Strength Training
2016
N/A
~50

Find a Location

Who is running the clinical trial?

Froedtert HospitalOTHER
9 Previous Clinical Trials
10,696 Total Patients Enrolled
University of Wisconsin, MilwaukeeLead Sponsor
50 Previous Clinical Trials
6,123 Total Patients Enrolled
Medical College of WisconsinOTHER
631 Previous Clinical Trials
1,181,938 Total Patients Enrolled

Media Library

Expiratory Muscle Strength Training Clinical Trial Eligibility Overview. Trial Name: NCT03975465 — N/A
Head and Neck Cancers Research Study Groups: Expiratory Muscle Strength Training, Pharyngeal Muscle Strengthening Exercises
Head and Neck Cancers Clinical Trial 2023: Expiratory Muscle Strength Training Highlights & Side Effects. Trial Name: NCT03975465 — N/A
Expiratory Muscle Strength Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03975465 — N/A
~2 spots leftby Oct 2025
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